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Rendell Baker Silicone Mask, #0
EUDAMEDClass IIa (EU MDR)
Ref AM0019Model (O) Mask
Identity
- Trade Name
- Rendell Baker Silicone Mask, #0 EUDAMED
- Device Name
- Reusable Silicone Mask EUDAMED
- Model / Reference
- (O) Mask EUDAMEDAM0019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810081750 EUDAMED
- Basic UDI-DI
- 471081008RNOMAP EUDAMED
- Direct Marketing DI
- 04710810081750 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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, #0 by GaleMed Corporation — 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 | 471081008RNOMAP | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 1a90445a-3fc6-417b-804e-3ad16894d77f 61 fields · synced Jun 18, 2026