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Rendell Baker Silicone Mask, #2
EUDAMEDClass IIa (EU MDR)
Ref AM0021Model (O) Mask
Identity
- Trade Name
- Rendell Baker Silicone Mask, #2 EUDAMED
- Device Name
- Reusable Mask EUDAMEDReusable Silicone Mask EUDAMED
- Model / Reference
- AM0021 EUDAMED(O) Mask EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980100505 EUDAMED04710810080753 EUDAMED
- Basic UDI-DI
- 69239801NR2KBSG EUDAMED471081008RNOMAP EUDAMED
- Direct Marketing DI
- 04710810080753 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, #2 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 b010b751-6ed9-47e3-9c75-9ef46eefcbf6 61 fields · synced Jul 31, 2026
- EUDAMED 2c874741-a8fa-4660-accc-98cc97ce4eda 61 fields · synced Jul 31, 2026