Hollister
by Hollister Incorporated United States EUDAMED
Ref 22335
EMDN A1001010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number610075D01P038S00409K | Date14 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- 1-Piece Closed Ostomy Pouch, Softflex
- Model / Reference
- 22335
- Primary DI / UDI-DI
- 05390166062161
- Basic UDI-DI
- 610075D01P038S00409K
- Unit of Use DI
- 00610075076451
- EMDN Code
- A1001010102 One-piece colostomy bags for non-retracted stoma, flat, with tissue cover
- 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 05390166062161|610075D01P038S00409K