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APL Valve, 60cmH2O
EUDAMEDClass IIa (EU MDR)
Ref AV0061Model (H) Ventilation Circuit
Identity
- Trade Name
- APL Valve, 60cmH2O EUDAMED
- Device Name
- NRV&Valve EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAV0061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 44710810103283 EUDAMED
- Basic UDI-DI
- 471081008NNH67S EUDAMED
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER 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
APL Valve, 60cmH2O 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 | 471081008NNH67S | 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 f9be06f3-750a-47c6-8833-3185550123e4 61 fields · synced Jul 28, 2026