← Back to catalogue
enScope™ Single Use Digital Flexible Cysto-Nephroscope
EUDAMEDClass IIa (EU MDR)
Ref CY-PL15R
Identity
- Trade Name
- enScope™ Single Use Digital Flexible Cysto-Nephroscope EUDAMED
- Device Name
- Single Use Digital Flexible Cysto-Nephroscope EUDAMED
- Model / Reference
- CY-PL15R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925776119678 EUDAMED
- Basic UDI-DI
- 69257761001001X3 EUDAMED
- EMDN Code
- Z12020702 CYSTOURETHROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
enScope™ Single Use Digital Flexible Cysto-Nephroscope by Ezisurg Medical 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 | 69257761001001X3 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ezisurg Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000006742
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b70ff8a6-9ccd-48ea-96d9-f202fd708532 61 fields · synced Jun 19, 2026