Hollister
by Hollister Incorporated 564 variants
Ref 9430
Hollister (9430) is a Class I device made by Hollister Incorporated, registered in EUDAMED on 1 Oct 2025 (Basic UDI-DI 610075D03P016S02249V), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number610075D03P016S02249V | Date1 Oct 2025 | StatusActive |
Official records
- EUDAMED public site 610075D03P016S02249V
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Urinary Night Drainage Bags
- Model / reference
- 9430
- Primary DI / UDI-DI
- 00610075071302, 05390166081162
- Basic UDI-DI
- 610075D03P016S02249V
- Unit of use DI
- 00610075094226
- EMDN code
- A06030301 Urine collection bags
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000027818
- Authorised representative
- Hollister ULC IE-AR-000022119
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