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Sterile Non-Vascular Guidewires
EUDAMEDClass IIa (EU MDR)
Ref GW02-35300Ref GW09-001Ref GW01-35450-SRef GW01-35260Ref GW01-35450Ref 21435400BS
Identity
- Trade Name
- Sterile Non-Vascular Guidewires EUDAMED
- Device Name
- Sterile Non-Vascular Guidewires EUDAMED
- Model / Reference
- GW02-35300 EUDAMEDGW09-001 EUDAMEDGW01-35450-S EUDAMEDGW01-35260 EUDAMEDGW01-35450 EUDAMED21435400BS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420051303731 EUDAMED05420051303984 EUDAMED05420051304110 EUDAMED05420051302826 EUDAMED05420051302505 EUDAMED05420051300136 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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Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
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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 (6)
- EUDAMED 37856eba-4847-4817-8a7c-784b7129c7fb 61 fields · synced Jul 16, 2026
- EUDAMED 36cf3f16-0220-4b5b-a954-0a0275be409a 61 fields · synced May 16, 2026
- EUDAMED ab8d6913-93d3-41f3-bf41-2d2877b28c8f 61 fields · synced May 17, 2026
- EUDAMED df89747e-6ca5-4502-b512-99b6836c264a 61 fields · synced May 17, 2026
- EUDAMED 43d6795a-7df7-4cc9-9d70-fb6779711f12 61 fields · synced May 17, 2026
- EUDAMED 01d1d053-d147-4fef-a044-aa7ab7f00afa 61 fields · synced May 18, 2026