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Durable Chamber, Adult
EUDAMEDClass IIa (EU MDR)
Ref AH0021Model (H) Ventilation Circuit
Identity
- Trade Name
- Durable Chamber, Adult EUDAMED
- Device Name
- Reusable Chamber EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAH0021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810116876 EUDAMED
- Basic UDI-DI
- 471081008RNH38G EUDAMED
- Direct Marketing DI
- 24710810116876 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
Durable Chamber, Adult 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 | 471081008RNH38G | 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 0e8808e4-9400-4c51-9e5b-cb99ccc57a70 61 fields · synced Jun 20, 2026