← Back to catalogue
Welllead Multi-vent Mask
EUDAMEDClass IIa (EU MDR)
Ref R01A07021YModel Adjustable Venturi Mask
Identity
- Trade Name
- Welllead Multi-vent Mask EUDAMED
- Device Name
- Multi-vent Mask EUDAMED
- Model / Reference
- Adjustable Venturi Mask EUDAMEDR01A07021Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944932767652 EUDAMED
- Basic UDI-DI
- 69449327FR01A15K8 EUDAMED
- EMDN Code
- R03010202 VENTURI MASKS 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 Multi-vent 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 | 69449327FR01A15K8 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 0b1f7dce-0b16-416d-bb78-084afc216735 61 fields · synced Jul 29, 2026