Identity
- Trade Name
- Obisk Disposable Type IIR Surgical Mask EUDAMED
- Device Name
- Obisk Disposable Surgical Masks EUDAMED
- Model / Reference
- OB11R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056423700060 EUDAMED
- Basic UDI-DI
- 50564237OB11RCM EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I 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
Obisk Disposable Type IIR Surgical Mask by Bluetree Medical Limited — 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 | 50564237OB11RCM | Class I | Active |
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Manufacturer
- Manufacturer
- Bluetree Medical Limited
- EUDAMED SRN
- GB-MF-000017859
- Authorised Representative
- Patient Guard Europe UG DE-AR-000007523
Sources (1)
- EUDAMED 0dfabde6-a50b-402e-a9af-4ed9873eda39 61 fields · synced Jun 20, 2026