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EndoSheath Protective Barrier
EUDAMEDFDA UDIClass I (EU MDR)
Ref CF 1.5Model CF 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 CST-4000 Cystoscope FDA UDI
- Model / Reference
- CF 1.5 EUDAMEDCF-1.5 FDA UDI
- Description
- EndoSheath Technology for CST-4000 Cystoscope FDA UDI
Identifiers
- Catalog Number
- 08-4102 FDA UDI
- Primary DI / UDI-DI
- 00874485003159 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00874485003159 EUDAMED
- 510(k) Number
- K071127 FDA UDI
- FDA Product Code
- HIH 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
- 884.1690 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-00874485003159 | 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 1d7e6ae7-9f93-46ec-9ec1-64e2dc0c4483 61 fields · synced Oct 6, 2026
- FDA UDI 5e4c52c6-abd8-4d67-a6ae-56761b867e99 36 fields · synced May 25, 2026