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Auto Chamber, Infant
EUDAMEDClass IIa (EU MDR)
Ref AH0038Model (H) Ventilation Circuit
Identity
- Trade Name
- Auto Chamber, Infant EUDAMED
- Device Name
- Chamber EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAH0038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 44710810117129 EUDAMED
- Basic UDI-DI
- 471081008NNH37L 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
Auto Chamber, Infant 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 | 471081008NNH37L | 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 7b4c5739-5292-4c87-96f4-adec6c51d1c6 61 fields · synced Jul 12, 2026