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Sil.Flex Catheter Mount, 22/15mm, 22F
EUDAMEDClass IIa (EU MDR)
Ref AB0143Model (I) Anesthesia Circuit
Identity
- Trade Name
- Sil.Flex Catheter Mount, 22/15mm, 22F EUDAMED
- Device Name
- Reusable Catheter Mount EUDAMED
- Model / Reference
- (I) Anesthesia Circuit EUDAMEDAB0143 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810110276 EUDAMED
- Basic UDI-DI
- 471081008RNI48M EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O 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
Sil.Flex Catheter Mount, 22/15mm, 22F 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 | 471081008RNI48M | 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 b47a2a1d-7835-4173-a4b0-cb2960e2d4c3 61 fields · synced Jul 11, 2026