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Silicone Flex Tube, 13cm, 22F, 15F
EUDAMEDClass IIa (EU MDR)
Ref AB0135Model (Q) Tubing
Identity
- Trade Name
- Silicone Flex Tube, 13cm, 22F, 15F EUDAMED
- Device Name
- Reusable Sil.Flex Hose EUDAMED
- Model / Reference
- (Q) Tubing EUDAMEDAB0135 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810083297 EUDAMED
- Basic UDI-DI
- 471081008RNQ197 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
Silicone Flex Tube, 13cm, 22F, 15F 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 | 471081008RNQ197 | 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 451b47c1-d74b-430a-8c8f-dfdcf2b49be7 61 fields · synced Jun 19, 2026