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Disposable Urinary Hydrophilic Guidewire
EUDAMEDClass IIa (EU MDR)
Ref HA-35-150Model HA-32-150,HS-32-150,HA-35-150,HS-35-150,HA-38-150,HS-38-150
Identity
- Device Name
- Disposable Urinary Hydrophilic Guidewire EUDAMED
- Model / Reference
- HA-32-150,HS-32-150,HA-35-150,HS-35-150,HA-38-150,HS-38-150 EUDAMEDHA-35-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941903600489 EUDAMED
- Basic UDI-DI
- 697182106Y0006B6 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
Disposable Urinary Hydrophilic 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 | 697182106Y0006B6 | 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 809080e0-7994-412b-8ba5-570f29e00a2e 61 fields · synced Jun 18, 2026