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 CST-5000 Cystoscope FDA UDI
- Model / Reference
- CV 2.1 EUDAMEDCV-2.1 FDA UDI
- Description
- EndoSheath Technology for CST-5000 Cystoscope FDA UDI
Identifiers
- Catalog Number
- 08-5101 FDA UDI
- Primary DI / UDI-DI
- 00874485003166 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00874485003166 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-00874485003166 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cogentix Medical, Inc.
- EUDAMED SRN
- US-MF-000041661
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED 80275491-07ce-4b0b-af33-97bcffb8a162 61 fields · synced Jun 18, 2026
- FDA UDI 228db24d-a998-4639-9591-4f3e5a314dc9 36 fields · synced May 29, 2026