Identity
- Trade Name
- PTFE Guidewire EUDAMED
- Device Name
- Guidewire EUDAMED
- Model / Reference
- BEPTS025150ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905080008101 EUDAMED
- Basic UDI-DI
- 8905080BUGW78 EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
PTFE Guidewire by Blue Neem Medical Devices Private Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: View Product >
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 | 8905080BUGW78 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Neem Medical Devices Private Limited
- EUDAMED SRN
- IN-MF-000021793
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (1)
- EUDAMED 401a2425-c0e3-41c4-bc18-0d60e72b99ee 61 fields · synced Jun 18, 2026