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Flexible Cystoscopes
EUDAMEDClass IIa (EU MDR)
Ref CY55I-24EUModel CY55H-24EU, CY55H-24US and etc.Ref CY55I-24US
Identity
- Device Name
- Flexible Cystoscopes EUDAMED
- Model / Reference
- CY55H-24EU, CY55H-24US and etc. EUDAMEDCY55I-24EU EUDAMEDCY55I-24US EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970034211090 EUDAMED06970034211106 EUDAMED
- Basic UDI-DI
- 697003421UBVU EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMEDItaly 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
Flexible Cystoscopes by Shanghai Anqing 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 | 697003421UBVU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000008487
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED bbc1262f-edba-4ed9-90f7-75726cea957e 61 fields · synced Oct 6, 2026
- EUDAMED 988cb24d-4fe8-4f91-8ae0-10f9be590717 61 fields · synced May 18, 2026