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EndoSheath Protective Barrier
EUDAMEDFDA UDIClass I (EU MDR)
Ref CV 1.5Model CV 1.5
Identity
- Trade Name
- EndoSheath Protective Barrier EUDAMEDEndoSheath Technology FDA UDI
- Generic Name
- Optical medical device procedural cover FDA UDI
- Device Name
- EndoSheath Protective Barrier EUDAMEDEndoSheath Technology for the CST-5000 Cystoscope FDA UDI
- Model / Reference
- CV 1.5 EUDAMEDCV-1.5 FDA UDI
- Description
- EndoSheath Technology for the CST-5000 Cystoscope FDA UDI
Identifiers
- Catalog Number
- 08-5102 FDA UDI
- Primary DI / UDI-DI
- 00874485003173 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00874485003173 EUDAMED
- 510(k) Number
- K072180 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Optical medical device procedural cover FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EndoSheath Protective Barrier by Cogentix Medical, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00874485003173 | 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 f2a00502-fe2d-4d2f-8b7a-c4491e96fef6 61 fields · synced Jul 10, 2026
- FDA UDI 13281a34-6701-4c43-9f9a-233f66d84ee5 36 fields · synced May 30, 2026