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Urological Guidewires
EUDAMEDClass IIa (EU MDR)
Ref IVX-UG-3215BSOModel IVX-UG-3215BSO; IVX-UG-3515BSO
Identity
- Device Name
- Urological Guidewires EUDAMED
- Model / Reference
- IVX-UG-3215BSO; IVX-UG-3515BSO EUDAMEDIVX-UG-3215BSO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950203334119 EUDAMED
- Basic UDI-DI
- 69502033UGBYA EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Urological Guidewires by Innovex Medical Co., Ltd. — 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 | 69502033UGBYA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innovex Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000015981
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0748a5ad-8c4e-4c76-8aa5-87347f3380ce 61 fields · synced Oct 6, 2026