Identity
- Device Name
- Single-use Flexible Cystoscope EUDAMED
- Model / Reference
- CY-E2E01R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972197483901 EUDAMED
- Basic UDI-DI
- 697219748CY4E EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES 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
Single-use Flexible Cystoscope by Hunan Vathin Medical Instrument 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 | 697219748CY4E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Vathin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000002593
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED e47e28a3-905b-47f7-8cae-a0cd7e74b35c 61 fields · synced May 30, 2026