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Adaptor for HiO2 Mask w/Valve
EUDAMEDClass IIa (EU MDR)
Ref AC0203Model (P) Connector
Identity
- Trade Name
- Adaptor for HiO2 Mask w/Valve EUDAMED
- Device Name
- Other Connector EUDAMED
- Model / Reference
- (P) Connector EUDAMEDAC0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810082900 EUDAMED
- Basic UDI-DI
- 471081008NNP88N EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP 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
Adaptor for HiO2 Mask w/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 | 471081008NNP88N | 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 267bcd96-cfcd-4a45-9834-821205bde776 61 fields · synced Jul 12, 2026