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PLS Valve, 10cmH2O, 22F
EUDAMEDClass IIa (EU MDR)
Ref AN0019Model (G) Bubble CPAP System
Identity
- Trade Name
- PLS Valve, 10cmH2O, 22F EUDAMED
- Device Name
- Accessories EUDAMED
- Model / Reference
- (G) Bubble CPAP System EUDAMEDAN0019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810115639 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
PLS Valve, 10cmH2O, 22F 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 9f25fbea-1491-4eb3-b39a-02fe66823c05 61 fields · synced Jun 19, 2026