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F2 NV Full Face Mask
EUDAMEDClass IIa (EU MDR)
Ref F2 NV2(Medium)Ref F2 NV1(Medium)Ref F2 NV2(Small)Ref F2 NV2(Large)Ref F2 NV1(Small)Ref BMC-FM2(Large)
Identity
- Trade Name
- F2 NV Full Face Mask EUDAMEDF2 Full Face Mask EUDAMED
- Device Name
- Mask EUDAMED
- Model / Reference
- F2 NV2(Medium) EUDAMEDF2 NV1(Medium) EUDAMEDF2 NV2(Small) EUDAMEDF2 NV2(Large) EUDAMEDF2 NV1(Small) EUDAMEDBMC-FM2(Large) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538360279 EUDAMED06948538360248 EUDAMED06948538360286 EUDAMED06948538360262 EUDAMED06948538360255 EUDAMED06948538360064 EUDAMED
- Basic UDI-DI
- 69485383STA01Z3 EUDAMED
- EMDN Code
- R0301010201,R0301010202 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
F2 NV Full Face Mask by BMC 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 | 69485383STA01Z3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BMC Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010157
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED a50f26ed-0d86-4b84-ad91-a236047514f1 61 fields · synced Oct 6, 2026
- EUDAMED 5a4a3c4e-2bf9-448e-ac53-44cfb4aac031 61 fields · synced May 17, 2026
- EUDAMED 0858551f-b3c1-4272-994e-ed657c952318 61 fields · synced May 17, 2026
- EUDAMED 5584f982-4893-4c1f-b961-7b74b033161b 61 fields · synced May 17, 2026
- EUDAMED 6206b8f7-67c5-4f0a-8623-525b0ed8c6e3 61 fields · synced May 19, 2026
- EUDAMED 8287d2bb-a7a9-4ad6-af76-436fdd0a8b78 61 fields · synced May 19, 2026