Hollister
by Hollister Incorporated United States EUDAMED
Ref 9822
EMDN A0699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number610075D03P016S0229A7 | Date15 Apr 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Drainable Faecal (Fecal) Collector, SoftFlex
- Model / Reference
- 9822
- Primary DI / UDI-DI
- 00610075103737
- Basic UDI-DI
- 610075D03P016S0229A7
- Unit of Use DI
- 00610075053001
- EMDN Code
- A0699 Drainage and fluid collection devices - other
- 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 00610075103737|610075D03P016S0229A7