Identity
- Trade Name
- Single-use Urinary Guide Wire EUDAMED
- Device Name
- Single-use Urinary Guide Wire EUDAMED
- Model / Reference
- UW-S2515S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926839812079 EUDAMED
- Basic UDI-DI
- 694831892a008MK EUDAMED
- Direct Marketing DI
- 06926839812079 EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Single-use Urinary Guide Wire by Anrei Medical (HZ) 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 | 694831892a008MK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Anrei Medical (HZ) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009964
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 77ac4ee2-c4d6-4fd8-bf91-d7b38fb38895 61 fields · synced Jun 18, 2026