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Nasal Mask
EUDAMEDClass IIa (EU MDR)
Ref N5B+(Medium)Ref N5(Extra Large)Ref N6S(Large)Ref N5B(Small)Ref N5A(Medium)Ref N5(Small)Ref N5B+(Extra Large)Ref N5A+(Large)Ref N5+(Medium)Ref N5(All Size Kit)Ref N5A+(Small)Ref N5(Medium)Ref N5H(Extra Large)Ref N5A+(All Size Kit)Ref N5B+(All Size Kit)Ref N6(Medium)Ref N6(All Size Kit)Ref N5BH(All Size Kit)Ref N5BH(Small)Ref N5AH(Medium)Ref N5(Large)Ref N5H(Large)Ref N6S(All Size Kit)Ref N5AH(Small)Ref N5BH(Large)Ref N5+(Extra Large)Ref N6(Large)Ref N5A+(Medium)Ref N5B(Medium)Ref N5A(Large)Ref N5A(Extra Large)Ref N5+(Large)
Identity
- Trade Name
- Nasal Mask EUDAMED
- Device Name
- Mask EUDAMED
- Model / Reference
- N5B+(Medium) EUDAMEDN5(Extra Large) EUDAMEDN6S(Large) EUDAMEDN5B(Small) EUDAMEDN5A(Medium) EUDAMEDN5(Small) EUDAMEDN5B+(Extra Large) EUDAMEDN5A+(Large) EUDAMEDN5+(Medium) EUDAMEDN5(All Size Kit) EUDAMEDN5A+(Small) EUDAMEDN5(Medium) EUDAMEDN5H(Extra Large) EUDAMEDN5A+(All Size Kit) EUDAMEDN5B+(All Size Kit) EUDAMEDN6(Medium) EUDAMEDN6(All Size Kit) EUDAMEDN5BH(All Size Kit) EUDAMEDN5BH(Small) EUDAMEDN5AH(Medium) EUDAMEDN5(Large) EUDAMEDN5H(Large) EUDAMEDN6S(All Size Kit) EUDAMEDN5AH(Small) EUDAMEDN5BH(Large) EUDAMEDN5+(Extra Large) EUDAMEDN6(Large) EUDAMEDN5A+(Medium) EUDAMEDN5B(Medium) EUDAMEDN5A(Large) EUDAMEDN5A(Extra Large) EUDAMEDN5+(Large) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538367322 EUDAMED06948538360903 EUDAMED06948538367940 EUDAMED06948538360705 EUDAMED06948538360477 EUDAMED06948538360439 EUDAMED06948538367346 EUDAMED06948538367261 EUDAMED06948538367223 EUDAMED06948538360552 EUDAMED06948538367285 EUDAMED06948538360446 EUDAMED06948538360873 EUDAMED06948538367308 EUDAMED06948538367353 EUDAMED06948538367452 EUDAMED06948538367490 EUDAMED06948538360866 EUDAMED06948538360835 EUDAMED06948538360804 EUDAMED06948538360453 EUDAMED06948538360774 EUDAMED06948538367971 EUDAMED06948538360798 EUDAMED06948538360859 EUDAMED06948538367247 EUDAMED06948538367445 EUDAMED06948538367278 EUDAMED06948538360699 EUDAMED06948538360484 EUDAMED06948538360910 EUDAMED06948538367216 EUDAMED
- Basic UDI-DI
- 69485383STA01Z3 EUDAMED
- Direct Marketing DI
- 06948538367940 EUDAMED06948538367971 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
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 (32)
- EUDAMED 17f00b47-b94c-4902-980e-905d4e6b92b4 61 fields · synced Oct 1, 2026
- EUDAMED bb5ae433-9a1e-4753-979c-9590ee1ffa0d 61 fields · synced May 16, 2026
- EUDAMED 3f9442dd-bf9e-4cec-bee0-c277dfa1b7d2 61 fields · synced May 16, 2026
- EUDAMED 7da286f6-0ca1-4e50-8a3e-f4e1dd44040b 61 fields · synced May 16, 2026
- EUDAMED c3087a62-6864-4ee4-93eb-f23a4ed55fc7 61 fields · synced May 17, 2026
- EUDAMED 0b5d89c6-1caa-4715-bece-354d1e8c4bd9 61 fields · synced May 17, 2026
- EUDAMED ac17214a-2ff9-4dc0-9da2-4e8bb3db26fd 61 fields · synced May 17, 2026
- EUDAMED e2b7a1f1-507a-4a69-9774-2daf00ce3531 61 fields · synced May 17, 2026
- EUDAMED 6372c3c2-2c13-4ab1-af26-67e3d0f8bf6f 61 fields · synced May 17, 2026
- EUDAMED e384505b-c4d9-4d44-9272-19ec17f8552b 61 fields · synced May 17, 2026
- EUDAMED fd283ab9-d1a6-4c1b-b00c-7fb1888ec137 61 fields · synced May 17, 2026
- EUDAMED 44082241-8d44-4685-b912-70e31bb093e7 61 fields · synced May 17, 2026
- EUDAMED 281f551d-3745-4b20-8e33-18cd88f6864c 61 fields · synced May 17, 2026
- EUDAMED 67aa1ec3-8661-4702-b63e-d4e73a691718 61 fields · synced May 17, 2026
- EUDAMED 57dab791-d2df-417f-9e3a-75238f099374 61 fields · synced May 17, 2026
- EUDAMED e16e8b23-63d2-4562-9d1d-fcf7ef039355 61 fields · synced May 17, 2026
- EUDAMED 5a2fa000-f9b4-4ca3-ba3a-6f6d8e3db6b0 61 fields · synced May 17, 2026
- EUDAMED acf0e025-e704-4aa1-aa88-68073c51043d 61 fields · synced May 17, 2026
- EUDAMED 8d3793e7-0627-4f5d-8613-866947678cbf 61 fields · synced May 17, 2026
- EUDAMED e1ce6a18-2737-4d92-ad95-5be5282c21f1 61 fields · synced May 18, 2026
- EUDAMED d175a077-c94b-4498-adc0-078978358574 61 fields · synced May 18, 2026
- EUDAMED e4532747-fdf9-40ef-9594-b51218b049d0 61 fields · synced May 18, 2026
- EUDAMED 4bb8821e-ac53-44de-a876-0a54f09ce893 61 fields · synced May 18, 2026
- EUDAMED 45ae44c1-59d6-4881-9c53-d333796f8341 61 fields · synced May 18, 2026
- EUDAMED 38db09cd-5452-42e5-bced-770b55889fca 61 fields · synced May 18, 2026
- EUDAMED 6b9a12e7-089d-4dce-88ba-60c1bbd209e1 61 fields · synced Jul 10, 2026
- EUDAMED a459bd69-0a4c-409b-8d9b-80a80f7b209f 61 fields · synced Jul 11, 2026
- EUDAMED 706bacb9-2e51-4f30-af7b-5c2d497b2d52 61 fields · synced Jul 12, 2026
- EUDAMED f3c3c369-31c9-4ac1-b6a1-896f96086023 61 fields · synced Jul 14, 2026
- EUDAMED fcc5d74c-ecc0-40e5-8bd8-14b8ffebaf6e 61 fields · synced Jul 20, 2026
- EUDAMED 979dd327-80b3-4889-8178-06552ef9378f 61 fields · synced Jul 23, 2026
- EUDAMED 78292379-e8a8-4ca5-9810-a883fa7b3f9d 61 fields · synced Aug 2, 2026