Hollister
by Hollister Incorporated United States EUDAMEDGUDID
Ref 78501
Product code EXBEMDN A108099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number610075D01P036S016094 | Date16 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00610075785018 | Date1 Dec 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Hollister EUDAMEDAdapt GUDID
- Generic Name
- Ostomy odour-absorbent/deodorizer
- Model / Ref / Catalog
- 78501
- Primary DI / UDI-DI
- 00610075785018
- Basic UDI-DI
- 610075D01P036S016094
- Unit of Use DI
- 30610075785019
- FDA Product Code
- EXB
- EMDN Code
- A108099 Accessory devices for abdominal ostomy - other
- GMDN Term
- Ostomy odour-absorbent/deodorizer
- Device Class
- Class I
- Regulation Number
- 876.5900
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
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 (19)
- 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
- Prescription Use: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 1729ddce-fdc4-4f4b-85a0-3cfa0728343a
- FDA UDI 18b88161-b71c-414b-8f54-a385d8872dad