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CST-5000 Series Video Cystoscope/Hysteroscope, PAL
EUDAMEDClass IIa (EU MDR)
Ref 08-5202
Identity
- Trade Name
- CST-5000 Series Video Cystoscope/Hysteroscope, PAL EUDAMED
- Device Name
- CST-5000 Series Video Cystoscope/Hysteroscope, PAL EUDAMED
- Model / Reference
- 08-5202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00874485000875 EUDAMED
- Basic UDI-DI
- B-00874485000875 EUDAMED
- EMDN Code
- Z12020711 VIDEO CYSTOURETHROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CST-5000 Series Video Cystoscope/Hysteroscope, PAL by Cogentix Medical, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00874485000875 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cogentix Medical, Inc.
- EUDAMED SRN
- US-MF-000041661
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (1)
- EUDAMED e3620fe2-664c-49a5-992c-87be9aa83482 61 fields · synced Jul 14, 2026