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Adult Smooth Breathing Circuit
EUDAMEDClass IIa (EU MDR)
Ref AB0348Model (H) Ventilation Circuit
Identity
- Trade Name
- Adult Smooth Breathing Circuit EUDAMED
- Device Name
- EVA Circuit EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAB0348 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810106712 EUDAMED
- Basic UDI-DI
- 471081008NNH17G EUDAMED
- EMDN Code
- R02010102 BREATHING CIRCUITS, WITH 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
Adult Smooth Breathing Circuit 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 | 471081008NNH17G | 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 92cabfe6-c660-4cea-87df-31b3d58f10f0 61 fields · synced Jul 9, 2026