← Back to catalogue
Full Face Mask
EUDAMEDClass IIa (EU MDR)
Ref F6(All Size Kit)Ref F5AS(Medium)Ref F5A+(All Size Kit)Ref F5A+(Medium)Ref F5AS(Small)Ref F5A+(Extra Small)Ref F5A(Extra Small)Ref HM01(Large)Ref F5(Large)Ref F5A+(Large)Ref F3(Medium)Ref F5A+(Small)Ref F4(Medium)Ref F5(Extra Large)Ref F6(Large)Ref F4(All Size Kit)Ref F6S(Small)Ref F6S(Medium Wide)Ref F6S(Medium)Ref F5A(All Size Kit)Ref F5(Medium)Ref F5+(Small)Ref F5+(Extra Large)Ref F5A(Medium)Ref F5(Extra Small)Ref F5+(Large)Ref F5A(Large)
Identity
- Trade Name
- Full Face Mask EUDAMED
- Device Name
- Mask EUDAMED
- Model / Reference
- F6(All Size Kit) EUDAMEDF5AS(Medium) EUDAMEDF5A+(All Size Kit) EUDAMEDF5A+(Medium) EUDAMEDF5AS(Small) EUDAMEDF5A+(Extra Small) EUDAMEDF5A(Extra Small) EUDAMEDHM01(Large) EUDAMEDF5(Large) EUDAMEDF5A+(Large) EUDAMEDF3(Medium) EUDAMEDF5A+(Small) EUDAMEDF4(Medium) EUDAMEDF5(Extra Large) EUDAMEDF6(Large) EUDAMEDF4(All Size Kit) EUDAMEDF6S(Small) EUDAMEDF6S(Medium Wide) EUDAMEDF6S(Medium) EUDAMEDF5A(All Size Kit) EUDAMEDF5(Medium) EUDAMEDF5+(Small) EUDAMEDF5+(Extra Large) EUDAMEDF5A(Medium) EUDAMEDF5(Extra Small) EUDAMEDF5+(Large) EUDAMEDF5A(Large) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538367209 EUDAMED06948538367094 EUDAMED06948538367575 EUDAMED06948538367551 EUDAMED06948538367100 EUDAMED06948538368442 EUDAMED06948538368404 EUDAMED06948538367766 EUDAMED06948538360491 EUDAMED06948538367544 EUDAMED06948538360651 EUDAMED06948538367568 EUDAMED06948538367131 EUDAMED06948538368398 EUDAMED06948538367162 EUDAMED06948538367155 EUDAMED06948538368145 EUDAMED06948538368152 EUDAMED06948538368138 EUDAMED06948538360736 EUDAMED06948538360507 EUDAMED06948538367520 EUDAMED06948538368435 EUDAMED06948538360538 EUDAMED06948538368381 EUDAMED06948538367506 EUDAMED06948538360521 EUDAMED
- Basic UDI-DI
- 69485383STA01Z3 EUDAMED
- Direct Marketing DI
- 06948538368442 EUDAMED06948538368404 EUDAMED06948538368398 EUDAMED06948538368145 EUDAMED06948538368152 EUDAMED06948538368138 EUDAMED06948538368435 EUDAMED06948538368381 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BMC Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010157
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (28)
- EUDAMED 93a0e605-4ebd-4bfe-9faa-902904d73689 61 fields · synced Sep 18, 2026
- EUDAMED 8a75bdac-88a8-4c2d-86e4-b66d30f22bd9 61 fields · synced May 16, 2026
- EUDAMED 744520e1-5b45-452a-8792-093445128148 61 fields · synced May 16, 2026
- EUDAMED ad48368d-fce3-4a79-a950-ac8d9d7c0d9c 61 fields · synced May 16, 2026
- EUDAMED 1c74b652-cea1-4ba9-af8d-ffe0004f9eb1 61 fields · synced May 16, 2026
- EUDAMED a72fcc9f-002f-4693-8678-1bb5baa4285c 61 fields · synced May 17, 2026
- EUDAMED 9cf438ee-3304-4925-a457-77b26763d935 61 fields · synced May 17, 2026
- EUDAMED 6fe70073-692f-4af0-a82c-7205d198bf05 61 fields · synced May 17, 2026
- EUDAMED 2d38ae5b-0aec-4446-9b5b-c6535452c120 61 fields · synced May 17, 2026
- EUDAMED d5c053c4-7007-4ff4-9b9d-5f3e67aab6ee 61 fields · synced May 17, 2026
- EUDAMED 83878fb2-d6d1-4f94-bfdd-8bffd12bd313 61 fields · synced May 17, 2026
- EUDAMED ab4989f4-d99a-4393-b2dd-a58d09412e16 61 fields · synced May 17, 2026
- EUDAMED ea2f6a51-8b5c-442b-ae9d-8f31c0d994cb 61 fields · synced May 17, 2026
- EUDAMED e4c2ec9b-ec6b-4d29-afe5-800dfac0e56a 61 fields · synced May 18, 2026
- EUDAMED 967886a9-e85c-4c58-afa7-883d69c65328 61 fields · synced May 18, 2026
- EUDAMED 094c7ab1-025c-43d4-a5c5-31a68b3f0906 61 fields · synced May 18, 2026
- EUDAMED 7c91f5d4-384c-468e-be86-fdd0a6122b4a 61 fields · synced May 18, 2026
- EUDAMED 74eb1f09-f058-4f93-8a28-2ef34ad1294f 61 fields · synced May 18, 2026
- EUDAMED 30895789-f94f-454d-a8f5-e9b9cff3128d 61 fields · synced May 18, 2026
- EUDAMED 28c4fe82-1643-4588-a87c-01cdbf8c1b5e 61 fields · synced Jul 9, 2026
- EUDAMED aa5a5dbd-b8ae-4218-be6c-bd17c2527ff7 61 fields · synced Jul 9, 2026
- EUDAMED 68d0cbe1-282b-4042-b907-96463609012c 61 fields · synced Jul 10, 2026
- EUDAMED 991ff02d-c19b-4715-bd38-8f235e3a791f 61 fields · synced Jul 14, 2026
- EUDAMED c47abcef-909e-42db-9b8b-34f8ae19657c 61 fields · synced Jul 15, 2026
- EUDAMED 4c8a465b-fb0b-4d23-9016-16d903a2fe53 61 fields · synced Jul 15, 2026
- EUDAMED 403035a6-d5dd-4a94-9d28-5fa4fe55ab58 61 fields · synced Jul 26, 2026
- EUDAMED 883d8c78-8b51-4ffb-8e48-6ba3b266ad17 61 fields · synced Aug 2, 2026
- EUDAMED 7e96d6ca-23c7-4584-83d7-2b038f85fd77 61 fields · synced Sep 18, 2026