Hollister
by Hollister Incorporated United States EUDAMED
Ref 97325-15
EMDN U070201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number610075D01P030S00606H | Date1 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Male Incontinence Sheath (Catheter)
- Model / Reference
- 97325-15
- Primary DI / UDI-DI
- 00610075070756
- Basic UDI-DI
- 610075D01P030S00606H
- Unit of Use DI
- 20610075070750
- EMDN Code
- U070201 Sheath catheter for the treatment of incontinence
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000027818
- Authorised representative
- Hollister ULC IE-AR-000022119
Other devices from Hollister Incorporated
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 00610075070756|610075D01P030S00606H