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Rendell Baker Silicone Mask, #3
EUDAMEDClass IIa (EU MDR)
Ref AM0022Model (O) Mask
Identity
- Trade Name
- Rendell Baker Silicone Mask, #3 EUDAMED
- Device Name
- Reusable Mask EUDAMEDReusable Silicone Mask EUDAMED
- Model / Reference
- AM0022 EUDAMED(O) Mask EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980100512 EUDAMED04710810080760 EUDAMED
- Basic UDI-DI
- 69239801NR2KBSG EUDAMED471081008RNOMAP EUDAMED
- Direct Marketing DI
- 04710810080760 EUDAMED
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMEDR03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands 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
Rendell Baker Silicone Mask, #3 by GaleMed (Xiamen) 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 | 69239801NR2KBSG | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED bca37985-44d3-45a4-98f9-d01e4bd3d188 61 fields · synced Jul 26, 2026
- EUDAMED 6269b212-6b65-4dab-881f-c20f314ad8fe 61 fields · synced Jul 26, 2026