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Disposable Medical Face Mask
EUDAMEDClass I (EU MDR)
Ref 11030700129Ref 0112-EM
Identity
- Device Name
- Disposable Medical Face Mask EUDAMED
- Model / Reference
- 11030700129 EUDAMED0112-EM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933265512299 EUDAMED06933265512305 EUDAMED
- Basic UDI-DI
- 69332655EM011235177T7 EUDAMED
- Direct Marketing DI
- 06933265512299 EUDAMED06933265512305 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Disposable Medical Face Mask by Blue Sail Medical Co., Ltd — Class I — 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 | 69332655EM011235177T7 | Class I | Active |
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Manufacturer
- Manufacturer
- Blue Sail Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000001139
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 2fcce0a5-8991-4bf1-95ba-6150b3663349 61 fields · synced Jul 8, 2026
- EUDAMED 345c708d-1e26-441d-9b63-d8ce02d32ceb 61 fields · synced May 17, 2026