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Welllead ETCO2 Sampling Cannula
EUDAMEDClass IIa (EU MDR)
Ref R01B02021YModel Without Filter
Identity
- Trade Name
- Welllead ETCO2 Sampling Cannula EUDAMED
- Device Name
- ETCO2 Sampling Cannula EUDAMED
- Model / Reference
- Without Filter EUDAMEDR01B02021Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944932751712 EUDAMED
- Basic UDI-DI
- 69449327FR01B06KC EUDAMED
- EMDN Code
- R0301020301 OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES) 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 Cannula 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 | 69449327FR01B06KC | 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 f8838f14-6494-4222-a33e-45fe996ab925 61 fields · synced Jul 29, 2026