Hollister
by Hollister Incorporated EUDAMED
Active
Ref 83125
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number610075D01P023S00316Y | Date9 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- 1-Piece High Output Ostomy Pouch, Flextend, Soft Convex
- Model / Reference
- 83125
- Primary DI / UDI-DI
- 00610075071920
- Basic UDI-DI
- 610075D01P023S00316Y
- Unit of Use DI
- 00610075088119
- EMDN Code
- A1001020202 One-piece ileostomy bags for retracted stoma, convex, 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
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