← Back to catalogue
Single-Use Digital Flexible Ureteroscope
EUDAMEDClass IIa (EU MDR)
Ref PUR12-4Model PUR12-1、PUR12-2、PUR12-3、PUR12-4、PUR12-5、PUR12-6、PUR12-S、PUR12-S1、PUR12-S2
Identity
- Device Name
- Single-Use Digital Flexible Ureteroscope EUDAMED
- Model / Reference
- PUR12-1、PUR12-2、PUR12-3、PUR12-4、PUR12-5、PUR12-6、PUR12-S、PUR12-S1、PUR12-S2 EUDAMEDPUR12-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202772908 EUDAMED
- Basic UDI-DI
- 697520277008JD EUDAMED
- Direct Marketing DI
- 06975202772908 EUDAMED
- EMDN Code
- Z12020705 NEPHROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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 Digital Flexible Ureteroscope by Hunan Endoso Life Technology 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 | 697520277008JD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED a5495c3e-d397-4be9-85bb-2eaa2ef67e92 61 fields · synced Jun 19, 2026