Identity
- Trade Name
- VISIB Disposable Transparent Medical Masks EUDAMED
- Device Name
- VISIB Disposable Transparent Medical Masks EUDAMED
- Model / Reference
- VB11RT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056423700435 EUDAMED
- Basic UDI-DI
- 50564237VB11RTC3 EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER 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
VISIB Disposable Transparent Medical Masks 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 | 50564237VB11RTC3 | 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 6548be32-b3a2-435f-bc25-bc066187acac 61 fields · synced Jul 14, 2026