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enScope™ Single Use Digital Flexible Cysto-Nephroscope
EUDAMEDClass IIa (EU MDR)
Ref CY-PL15S
Identity
- Trade Name
- enScope™ Single Use Digital Flexible Cysto-Nephroscope EUDAMED
- Device Name
- Single Use Digital Flexible Cysto-Nephroscope EUDAMED
- Model / Reference
- CY-PL15S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925776121909 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 |
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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 2762d38b-b1a6-4787-b034-282b1e89d6c0 61 fields · synced Jun 18, 2026