Identity
- Trade Name
- Twister Guidewire EUDAMED
- Device Name
- Guidewire EUDAMED
- Model / Reference
- BTWN025150ST EUDAMEDBTWN035150ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905080008194 EUDAMED08905080008217 EUDAMED
- Basic UDI-DI
- 8905080BUGW78 EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Twister 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 (2)
- EUDAMED f91f631e-d86a-451c-a245-37dd9d342c6e 61 fields · synced Oct 6, 2026
- EUDAMED be5478a0-1a67-4e20-96b8-4cdb8a19d24f 61 fields · synced May 18, 2026