← Back to catalogue
PTFE Guidewire
EUDAMEDClass IIa (EU MDR)
Ref BEPTS025150JTRef BEPTS035150JTRef BEPTS038150JTRef BEPTS028150STRef BEPTS038150STRef BEPTS028150JTRef BEPTS035150ST
Identity
- Trade Name
- PTFE Guidewire EUDAMED
- Device Name
- Guidewire EUDAMED
- Model / Reference
- BEPTS025150JT EUDAMEDBEPTS035150JT EUDAMEDBEPTS038150JT EUDAMEDBEPTS028150ST EUDAMEDBEPTS038150ST EUDAMEDBEPTS028150JT EUDAMEDBEPTS035150ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905080008149 EUDAMED08905080008170 EUDAMED08905080008187 EUDAMED08905080008118 EUDAMED08905080008125 EUDAMED08905080008156 EUDAMED08905080000426 EUDAMED
- Basic UDI-DI
- 8905080BUGW78 EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDCzechia 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blue Neem Medical Devices Private Limited
- EUDAMED SRN
- IN-MF-000021793
- Authorised Representative
- Arazy Group (Ireland) Ltd. IE-AR-000000093
Sources (7)
- EUDAMED 60ea413c-cb4c-4312-a331-9ef885e2bab7 61 fields · synced Oct 6, 2026
- EUDAMED e7dc53cc-988e-4825-b97d-75a0286964c0 61 fields · synced May 17, 2026
- EUDAMED 89ae8d59-48ef-45c2-83af-d70823928431 61 fields · synced May 17, 2026
- EUDAMED c1bae1bd-81f7-480d-a587-c4933920dd25 61 fields · synced May 18, 2026
- EUDAMED 9e651b19-cab6-4b15-aef5-c9c262d8e8a4 61 fields · synced May 18, 2026
- EUDAMED f235ed8b-9318-4dcc-af69-37f7f5555cc9 61 fields · synced May 18, 2026
- EUDAMED 7302f994-1168-4a1f-bbed-0ffef7f980c9 61 fields · synced May 19, 2026