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Disposable Urinary Hydrophilic Guidewire
EUDAMEDClass IIa (EU MDR)
Ref HA-32-150Model HA-32-150,HS-32-150,HA-35-150,HS-35-150,HA-38-150,HS-38-150Ref HA-38-150Ref HS-35-150Ref HS-32-150
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-32-150 EUDAMEDHA-38-150 EUDAMEDHS-35-150 EUDAMEDHS-32-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941903600465 EUDAMED16941903600502 EUDAMED16941903600540 EUDAMED16941903600526 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
Introducing the Disposable Urinary Hydrophilic Guidewire, a cutting-edge medical device designed for minimally invasive urinary procedures. Our device features advanced hydrophilic technology, allowing for smooth navigation through urinary tract passages. With its durable and sterilizable design, it is ideal for use in clinical settings.
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 (4)
- EUDAMED 0ea10788-6400-4061-a6f9-215ee7c5faf8 61 fields · synced Oct 6, 2026
- EUDAMED 7ff718f8-8aab-455e-b25d-686247de1cca 61 fields · synced May 18, 2026
- EUDAMED 5f0ecac9-c243-410a-b1ba-c454e275b1bf 61 fields · synced May 18, 2026
- EUDAMED c1c486a2-3e50-4811-8cd0-3e8ebce6539a 61 fields · synced May 18, 2026