How to verify a CE mark on imported respiratory devices: what's real, what's fake

The CE mark is the most commonly-invoked certification on Indian-market respiratory equipment. It also happens to be the one most often misrepresented. A consumer looking at a carton that says “CE Certified” typically has no way to tell whether the mark is a genuine European conformity assessment by a Notified Body, a declaration of conformity by the manufacturer for a self-certifiable product class, or a counterfeit “China Export” mark designed to look like CE at a glance.

This article covers what a genuine CE mark actually consists of, how to verify its validity against the EU database, the counterfeit patterns that flood the Indian market, the distinction between CE, FDA, CDSCO, and ISO 13485 (four different certifications that cover four different things), the Indian import documents that should accompany a legitimately-imported device, and the red flags that identify a unit whose CE claim cannot be trusted.

What a genuine CE mark is

The CE mark (Conformité Européenne) indicates that a product complies with the applicable European Union directive or regulation. For medical devices, the regulation is now the EU Medical Device Regulation 2017/745 (MDR), which replaced the earlier Medical Device Directive 93/42/EEC (MDD) and In Vitro Diagnostic Medical Devices Directive (IVDD) in full force from May 2021.

Under MDR 2017/745, medical devices are classified I, IIa, IIb, or III by risk:

• Class I — low risk. Most can be self-certified by the manufacturer (Declaration of Conformity). Oxygen masks, tubing, suction catheters.
• Class Is, Im, Ir — Class I devices with sterile, measuring, or reusable features. Require Notified Body assessment of the specific feature.
• Class IIa — moderate risk. Nebuliser compressors, some monitoring devices. Require Notified Body involvement.
• Class IIb — moderate-high risk. Oxygen concentrators, CPAP, BiPAP, therapeutic ventilators. Require Notified Body involvement.
• Class III — high risk. Implantables, certain life-support equipment. Require Notified Body plus additional clinical evaluation.

For home respiratory equipment — concentrators, CPAP, BiPAP, POCs — the relevant EU class is IIa or IIb. These devices cannot be self-certified. A Notified Body must assess the device and issue an EC certificate under MDR 2017/745 before the manufacturer can affix the CE mark.

The three elements of a genuine CE mark on Class IIa/IIb devices

A legitimate CE mark on a Class IIa/IIb medical device has three elements visible on the label:

1. The “CE” logo itself, in the specific EU-mandated typography. Letters of equal size; spacing per the official specification. Commonly reproduced accurately but not always.
2. The four-digit Notified Body identification number immediately adjacent to or below the CE logo. Every Notified Body designated under MDR 2017/745 carries a four-digit number (e.g., 0123, 0459, 0197, 2797). This number identifies the specific body that performed the assessment.
3. The manufacturer’s name and EU authorised representative (if the manufacturer is outside the EU).

A CE mark without a four-digit Notified Body number on a Class IIa/IIb device is invalid. The manufacturer is not authorised to affix such a mark; either the device is lower-risk than claimed (and the label is wrong about its class), or the manufacturer has self-affixed without the required Notified Body assessment.

How to verify the Notified Body number

The EU maintains a public database, NANDO (New Approach Notified and Designated Organisations), which lists every designated Notified Body, their four-digit number, the directives and regulations they are authorised to assess under, and the scope of their designation.

Verification steps for a specific CE mark:

1. Note the four-digit number on the product label (e.g., “CE 0123”). If no number is visible on a Class IIa/IIb device, the mark is suspect.
2. Look up the number on NANDO. The search interface returns the Notified Body’s name, country of designation, and scope.
3. Verify the scope covers medical devices under MDR 2017/745. A Notified Body designated for toys or construction products cannot legitimately assess a medical device. Some Notified Bodies hold multiple designations — the scope should list MDR 2017/745 for medical device certification.
4. Check the body is currently active. NANDO lists current designations; bodies that have been withdrawn are marked.
5. Cross-check with the manufacturer. Request the EC certificate from the manufacturer (or the Indian importer). The EC certificate names the Notified Body, the device covered, the certificate number, and the validity period. A genuine manufacturer of a Class IIa/IIb device holds an EC certificate that they should be willing to share on request.

The EC certificate is the document that actually authorises the CE mark. The CE mark on the label is a summary of it.

The “China Export” counterfeit

The most widespread CE-mark counterfeit pattern uses what has colloquially been called the “China Export” logo. It is a reproduction of the CE mark with subtly different spacing between the C and E — specifically, the C and E are closer together in the counterfeit version than in the genuine EU mark. No Notified Body number accompanies it, and the manufacturer intends it to be read as “China Export” rather than as a European conformity mark.

The European Commission has acknowledged the ambiguity but there is no official “China Export” registration; the mark has no legal meaning. When it appears on a medical device label, the intent is to confuse a buyer who is skimming for “CE” and does not examine the spacing.

Signs that distinguish a counterfeit from a genuine CE mark:

• Letter spacing. Genuine CE: clear gap between C and E. Counterfeit: C and E almost touching.
• Absence of Notified Body number. A Class IIa/IIb medical device with CE but no four-digit number is either miscertified or counterfeit.
• Font inconsistency. Genuine CE mark uses a specific typography; printed labels sometimes use generic sans-serif that looks close but not right.
• No EU authorised representative named. Non-EU manufacturers must appoint an Authorised Representative (EC REP) located in the EU. A label with “CE” and a Chinese manufacturer address but no EC REP listed is non-compliant.

The four certifications — and how they differ

Buyers routinely conflate CE, FDA, CDSCO, and ISO 13485. Each means something different.

CE. European Union conformity. Device can be sold in the European Economic Area. Class IIa/IIb devices require Notified Body assessment. CE does not authorise sale in India, the US, or elsewhere.

FDA (US Food and Drug Administration). US market authorisation. Depending on the device, the pathway is 510(k) clearance (for most Class II devices including CPAP, BiPAP, concentrators) or Premarket Approval (PMA, for higher-risk devices). FDA clearance does not authorise sale in India. (US FDA)

CDSCO (Central Drugs Standard Control Organization). Indian market authorisation under the Medical Device Rules 2017 (MDR 2017). Class C devices (oxygen concentrators, CPAP, BiPAP, etc.) require CDSCO import or manufacturing licence. CDSCO is the only authorisation that makes a device legally sellable in India.

ISO 13485. A quality management system standard for medical device manufacturers. It applies to the manufacturer’s organisation, not to a specific device. An ISO 13485-certified manufacturer has a QMS that meets the standard; this does not by itself mean any specific device is approved in any specific market.

A correctly documented Indian-market concentrator typically carries:

• A CDSCO import licence number (the one that matters for Indian legality)
• ISO 13485 reference for the manufacturer’s QMS
• CE mark with Notified Body number if the manufacturer also supplies the EU market
• FDA 510(k) clearance if the manufacturer also supplies the US market

Products may have one, some, or all of these. The only one that is legally required for sale in India is the CDSCO licence. The others signal that the manufacturer has met the regulatory bar in another market, which is useful market signal but not an Indian legal requirement.

Indian import documents that should exist

A device imported into India passes through customs on the strength of specific documents. Behind the CE-marked product on the dealer’s shelf, the following paperwork exists if the importation is legitimate:

1. Form MD-14 (import registration) — filed by the importer with CDSCO to register the specific device for import.
2. Form MD-15 (import licence) — granted by CDSCO after registration, authorising the importer to import and sell the specific device.
3. Form 41 — predecessor licence under the earlier Drugs and Cosmetics Rules, still referenced for some device categories during the transition.
4. Bill of entry — the customs import record identifying the specific shipment, the importer, and the duty paid.
5. Importer’s letter of authorisation from the manufacturer — the manufacturer’s formal appointment of the Indian importer.
6. Technical documentation held by the importer as part of the MDR 2017 compliance file.

A legitimate dealer — or at minimum the importer — should be able to produce the import licence (MD-15 or Form 41) for the specific device on request. Dealers who cannot produce this, or who deflect the question, are operating outside the regulated supply chain.

Red flags that identify a questionable CE claim

Patterns that indicate the CE mark on a specific device should not be trusted:

1. No Notified Body number adjacent to the CE logo on a Class IIa/IIb device (concentrators, CPAP, BiPAP).
2. Notified Body number that does not resolve in the NANDO database.
3. Notified Body whose scope does not cover medical devices under MDR 2017/745.
4. No EU authorised representative (EC REP) named on the label for a non-EU manufacturer.
5. No Indian importer named on the unit, or the named importer’s details (address, CDSCO licence) are non-verifiable.
6. Labelling inconsistencies — different manufacturer addresses on carton versus unit, different model numbers, mismatched serial-number formats.
7. Refusal by dealer to produce either the EC certificate, the CDSCO import licence, or the manufacturer’s authorisation letter.
8. Price materially below the authorised importer’s range for the equivalent model.
9. Manual, labels, and packaging in languages inconsistent with the declared country of manufacture (e.g., EU-only language on a declared India-market product).
10. “CE” logo with letter-spacing that looks wrong on close inspection — C and E almost touching.

Any one of these is a caution; multiple together are a strong signal the device is outside the authorised supply chain.

What to do when a red flag appears

For a patient or family who has already bought a unit and is uncertain:

1. Contact the manufacturer directly (email or global customer service phone line listed on the manufacturer’s official website) with the serial number. Genuine manufacturers will verify whether the serial number is registered and whether the Indian importer listed on the unit is authorised.
2. Contact the CDSCO helpline or state drug controller to inquire whether the unit’s import licence is on record. CDSCO has a materiovigilance channel and general medical device queries are answered.
3. Compare the unit against the manufacturer’s product photographs and specifications on the official brand website. Counterfeits often have visible cosmetic differences once a reference image is in hand.
4. Verify the Notified Body in NANDO if a number is present.
5. Keep the purchase invoice and all packaging intact — if the unit proves non-compliant, consumer-forum action against the dealer requires documented evidence of sale.

For a buyer yet to commit:

1. Ask for the EC certificate copy and the CDSCO import licence copy before payment. A legitimate dealer will provide both; a grey-market dealer will not.
2. Call the manufacturer’s authorised Indian importer (listed on the brand’s official website) and confirm the dealer is in their authorised network.
3. Do not pay the balance until the serial number has been confirmed with the manufacturer or importer.

The COVID-era legacy

The 2020–2021 COVID-19 demand surge flooded global medical device supply chains. Indian customs records show a spike in concentrator and pulse-oximeter imports during this period, with a meaningful fraction routing through non-standard channels. Counterfeit CE marks, self-declared “CE certification” on Class IIa/IIb devices that required Notified Body assessment, and outright fake certificates were documented in multiple investigations during that period. (CDSCO)

Units sold during that window are still in the field and are approaching the end of their rated life. Verifying the CE and CDSCO credentials retrospectively is worth doing — if the unit turns out to be grey-market, the family should factor this into the decision about whether to invest in a service call on the existing unit or to replace it with a legitimately-imported one.

Practical takeaway

Treat CE as a piece of information, not a seal of quality. For a Class IIa/IIb respiratory device in India, a valid CE mark has three visible elements: the CE logo, a four-digit Notified Body number, and the EU authorised representative. Look up the Notified Body in NANDO; verify its scope covers medical devices under MDR 2017/745. The CE mark does not replace CDSCO approval — India’s Class C import licence is the regulatory bar for legality of sale here. Demand both the EC certificate and the CDSCO import licence (Form MD-15) from the dealer before payment; a legitimate chain will produce both. If the CE logo has no Notified Body number, or the Notified Body does not resolve, or no Indian importer is named, or the dealer refuses documentation requests, do not buy. The difference between a properly-certified unit and a grey-market one is service-network access, warranty enforceability, and the regulatory paper trail that survives the dealer going out of business.