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Welllead ETCO2 Sampling Oxygen Mask
EUDAMEDClass IIa (EU MDR)
Ref R01A160210Model without Filter
Identity
- Trade Name
- Welllead ETCO2 Sampling Oxygen Mask EUDAMED
- Device Name
- ETCO2 Sampling Oxygen Mask EUDAMED
- Model / Reference
- without Filter EUDAMEDR01A160210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936881190162 EUDAMED
- Basic UDI-DI
- 69449327FR01A12K2 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
No
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
Category: Nasal oxygen cannula, basic
Welllead ETCO2 Sampling Oxygen Mask by Well Lead Medical Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69449327FR01A12K2 | 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 86e29c9d-faa3-41e7-9270-a4923a2f8805 61 fields · synced Jul 15, 2026