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Single-Use Digital Flexible Ureteroscope
EUDAMEDClass IIa (EU MDR)
Ref PUR12-2Model PUR12-1、PUR12-2、PUR12-3、PUR12-4、PUR12-5、PUR12-6、PUR12-S、PUR12-S1、PUR12-S2Ref PUR12-SRef PUR12-S2Ref PUR12-6
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 EUDAMEDPUR12-2 EUDAMEDPUR12-S EUDAMEDPUR12-S2 EUDAMEDPUR12-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202773066 EUDAMED06975202772878 EUDAMED06975202772946 EUDAMED06975202772922 EUDAMED
- Basic UDI-DI
- 697520277008JD EUDAMED
- Direct Marketing DI
- 06975202773066 EUDAMED06975202772878 EUDAMED06975202772946 EUDAMED06975202772922 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 |
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Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (4)
- EUDAMED bce87c2c-888d-404f-a930-387fd13114c1 61 fields · synced Sep 18, 2026
- EUDAMED 66127156-fe95-43a8-a341-08520d5c112b 61 fields · synced May 17, 2026
- EUDAMED 0a38821c-9419-4bd4-af0f-4d090dc9a931 61 fields · synced May 18, 2026
- EUDAMED adb3fa79-f224-4a08-84b0-afab99b10486 61 fields · synced May 18, 2026