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Silicone J-Circuit, Adult
EUDAMEDClass IIa (EU MDR)
Ref AB0344Model (H) Ventilation CircuitRef AB0090
Identity
- Trade Name
- Silicone J-Circuit, Adult EUDAMED
- Device Name
- Silicone Circuit EUDAMEDReusable Silicone Circuit EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAB0344 EUDAMEDAB0090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810106682 EUDAMED24710810103531 EUDAMED
- Basic UDI-DI
- 471081008NNHB8G EUDAMED471081008RNHB9C EUDAMED
- Direct Marketing DI
- 24710810103531 EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMEDR02010102 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
Silicone J-Circuit, 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 | 471081008NNHB8G | 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 (2)
- EUDAMED 67de0e06-cfa7-49f7-aebb-6fa40a1ed2cd 61 fields · synced Jul 13, 2026
- EUDAMED 42edfd1b-628f-4a42-87be-eb66d05fd292 61 fields · synced Jul 13, 2026