Identity
- Device Name
- Hybrid Stripe Guidewire EUDAMED
- Model / Reference
- UZA-35-90 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941903607344 EUDAMED
- Basic UDI-DI
- 697182106Y0031B5 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
Hybrid Stripe Guidewire by MicroPort Urocare (Jiaxing) 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 | 697182106Y0031B5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MicroPort Urocare (Jiaxing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002345
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED d4be1bcb-c4ae-461e-9868-5eb45c0738ca 61 fields · synced Jun 19, 2026