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CST-4000 Series Fiberoptic Cystoscope/Hysteroscope
EUDAMEDFDA UDIClass I (EU MDR)
Ref 08-4201
Identity
- Trade Name
- CST-4000 Series Fiberoptic Cystoscope/Hysteroscope EUDAMEDFlexible Fiberoptic Cystoscope FDA UDI
- Generic Name
- Flexible fibreoptic cystoscope FDA UDI
- Device Name
- CST-4000 Series Fiberoptic Cystoscope/Hysteroscope EUDAMED
- Model / Reference
- 08-4201 EUDAMEDCST-4000 FDA UDI
Identifiers
- Catalog Number
- 08-4201 FDA UDI
- Primary DI / UDI-DI
- 00874485001599 EUDAMEDFDA UDI
- Basic UDI-DI
- 087448500CST4000CX EUDAMED
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- Z12020701,Z12020704 EUDAMED
- GMDN Term
- Flexible fibreoptic cystoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
CST-4000 Series Fiberoptic Cystoscope/Hysteroscope by Cogentix Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 087448500CST4000CX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED e6333582-bb88-42da-9a37-42a07fc6dbed 61 fields · synced Jun 19, 2026
- FDA UDI f576162a-1a8b-4aef-b00b-afe6196d4636 34 fields · synced May 30, 2026