Identity
- Trade Name
- HiWire EUDAMED
- Device Name
- Guidewire: Hydrophilic (Non-Vascular) EUDAMED
- Model / Reference
- HW-038150-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816349015175 EUDAMED
- Basic UDI-DI
- 081634901HydroUROE2 EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
HiWire by Lake Region Medical — 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 | 081634901HydroUROE2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lake Region Medical
- EUDAMED SRN
- US-MF-000033013
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c4ec4f65-e106-410c-972c-3fbd9a46a5ee 61 fields · synced Oct 7, 2026