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Silicone Circuit, Adult 150cm w/2WT
EUDAMEDClass IIa (EU MDR)
Ref AB0330Model (H) Ventilation CircuitRef AB0076Ref AB0074Ref AB0075
Identity
- Trade Name
- Silicone Circuit, Adult 150cm w/2WT EUDAMEDSilicone Circuit, Adult 120cm w/2WT EUDAMED
- Device Name
- Silicone Circuit EUDAMEDReusable Silicone Circuit EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAB0330 EUDAMEDAB0076 EUDAMEDAB0074 EUDAMEDAB0075 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810106617 EUDAMED34710810105860 EUDAMED24710810087695 EUDAMED24710810111253 EUDAMED
- Basic UDI-DI
- 471081008NNHB8G EUDAMED471081008RNHB9C EUDAMED
- Direct Marketing DI
- 34710810105860 EUDAMED24710810087695 EUDAMED24710810111253 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
Silicone Circuit, Adult 150cm w/2WT 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 (4)
- EUDAMED ab6d7c45-0e70-4aa1-a6f2-561fb4ec14a0 61 fields · synced Jul 31, 2026
- EUDAMED cdb818f4-bbff-4379-819e-170f64aed256 61 fields · synced Jun 18, 2026
- EUDAMED 02e2f614-3b15-4e85-868d-8799f786ee26 61 fields · synced Jul 10, 2026
- EUDAMED cb6861d6-832c-4b02-8a33-7d7ac11d9c24 61 fields · synced Jul 11, 2026