Hollister
by Hollister Incorporated 564 variants
Part of a family of 29 devices: see the family page
Ref 540232
Hollister (540232) is a Class I device made by Hollister Incorporated, registered in EUDAMED on 21 Mar 2025 (Basic UDI-DI 610075D01P040S00036N), active as of 24 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 | Number610075D01P040S00036N 00610075089215 | Date21 Mar 2025 | StatusActive |
Official records
- EUDAMED public site 610075D01P040S00036N
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- Withdrawn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
- 1-Piece Drainable Ostomy Pouch, CeraPlus, Soft Convex
- Model / reference
- 540232
- Primary DI / UDI-DI
- 00610075089215
- Basic UDI-DI
- 610075D01P040S00036N
- Unit of use DI
- 20610075089219
- EMDN code
- A1001010202 One-piece colostomy bags for retracted stoma, convex, with tissue cover
- 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
Similar devices in this category
Other devices filed under ONE PIECE COLOSTOMY BAGS.
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- Ostomy Bag N/A by Dongguan Kangda Medical Technology Co., Ltd
- Alterna 17467 by Coloplast A/S
- One system colostomy bag 101085 by Wuhan Sitaili Medical Apparatus Development Co., Ltd.
- One system colostomy bag 101060 by Wuhan Sitaili Medical Apparatus Development Co., Ltd.