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Welllead ETCO2 Sampling Oxygen Mask
EUDAMEDClass IIa (EU MDR)
Ref R01A16023XModel With Filter
Identity
- Trade Name
- Welllead ETCO2 Sampling Oxygen Mask EUDAMED
- Device Name
- ETCO2 Sampling Oxygen Mask EUDAMED
- Model / Reference
- With Filter EUDAMEDR01A16023X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936881190049 EUDAMED
- Basic UDI-DI
- 69449327FR01A10JW EUDAMED
- EMDN Code
- R03010299 OXYGEN THERAPY MASKS AND NASAL CANNULAS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Welllead ETCO2 Sampling Oxygen Mask by Well Lead Medical Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69449327FR01A10JW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000006728
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 438ab173-df44-4032-9453-04371c96022e 61 fields · synced Jul 26, 2026