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Bubble PAP Valve
EUDAMEDClass IIa (EU MDR)
Ref AN0018 Model (G) Bubble CPAP System
Identity
- Trade Name
- Bubble PAP Valve EUDAMED
- Device Name
- Accessories EUDAMED
- Model / Reference
- (G) Bubble CPAP System EUDAMEDAN0018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810117466 EUDAMED
- Basic UDI-DI
- 471081008NNG17D EUDAMED
- EMDN Code
- R02010401 CPAP CIRCUITS 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
Bubble PAP Valve 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 | 471081008NNG17D | 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 b9f8818e-6f37-4aba-a8a8-6ba8abae1ff9 61 fields · synced Jun 18, 2026