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Single-use Flexible Video Cystoscope
EUDAMEDClass IIa (EU MDR)
Ref DCYS2-222HPModel DCYS2-222HP, DCYS2-222HPR, DCYS2-223HP, DCYS2-223HPRRef DCYS2-222HPRRef DCYS-100HLPModel DCYS-100HLP, DCYS-100HLPRRef DCYS2-223HPRef DCYS-100HLPR
Identity
- Trade Name
- Single-use Flexible Video Cystoscope EUDAMED
- Device Name
- Single-use Flexible Video Cystoscope EUDAMED
- Model / Reference
- DCYS2-222HP, DCYS2-222HPR, DCYS2-223HP, DCYS2-223HPR EUDAMEDDCYS2-222HP EUDAMEDDCYS2-222HPR EUDAMEDDCYS-100HLP, DCYS-100HLPR EUDAMEDDCYS-100HLP EUDAMEDDCYS2-223HP EUDAMEDDCYS-100HLPR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974235401298 EUDAMED06974235401304 EUDAMED06974235401021 EUDAMED06974235401311 EUDAMED06974235401045 EUDAMED
- Basic UDI-DI
- 697423540DCNSJW EUDAMED697423540DCYSKX EUDAMED
- Direct Marketing DI
- 06974235401021 EUDAMED
- EMDN Code
- Z12020711 VIDEO CYSTOURETHROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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 Video Cystoscope by Himaging Technology (Shanghai) 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 | 697423540DCNSJW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Himaging Technology (Shanghai) Co., Ltd.
- EUDAMED SRN
- CN-MF-000028002
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED 553f5492-b602-4f69-aece-c59001356a8f 61 fields · synced Sep 17, 2026
- EUDAMED 6eb65be7-b91e-4f18-989e-74a36ae45124 61 fields · synced May 18, 2026
- EUDAMED 45d49dbb-551b-4a11-852c-dce55cd36b4b 61 fields · synced May 18, 2026
- EUDAMED 1d15ddff-bbeb-4ba0-a3ca-bcb3e690c070 61 fields · synced May 18, 2026
- EUDAMED a3161415-ed87-414c-ad9c-396f4ded7221 61 fields · synced May 19, 2026