Identity
- Trade Name
- Sterile Non-Vascular Guidewires EUDAMED
- Device Name
- Sterile Non-Vascular Guidewires EUDAMED
- Model / Reference
- GW01-25450 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420051303519 EUDAMED
- Basic UDI-DI
- 54200513-TF11-NGW-SU-GT EUDAMED
- EMDN Code
- K01020114 MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
Sterile Non-Vascular Guidewires by G-Flex Flexible Instruments Europe — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 54200513-TF11-NGW-SU-GT | Class IIa | Active |
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Manufacturer
- Manufacturer
- G-Flex Flexible Instruments Europe
- EUDAMED SRN
- BE-MF-000000623
Sources (1)
- EUDAMED 566254bb-17de-4768-a2db-e435233bf90b 61 fields · synced Jun 18, 2026