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N4 Nasal Mask
EUDAMEDClass IIa (EU MDR)
Ref NM4(Medium)Ref NM4(Large)Ref NM4(Small)
Identity
- Trade Name
- N4 Nasal Mask EUDAMED
- Device Name
- Mask EUDAMED
- Model / Reference
- NM4(Medium) EUDAMEDNM4(Large) EUDAMEDNM4(Small) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538360163 EUDAMED06948538360156 EUDAMED06948538360170 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
N4 Nasal 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 (3)
- EUDAMED 64a121bc-ee85-45c5-968f-7e9185864e39 61 fields · synced Jul 19, 2026
- EUDAMED 109d678a-5fb6-420b-8184-60270ef810bd 61 fields · synced May 18, 2026
- EUDAMED d89da787-a360-43d8-98d1-3c761fa6ed5f 61 fields · synced May 18, 2026