Hollister
by Hollister Incorporated United States EUDAMEDGUDID
Ref 7815
Product code EXEEMDN A108001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00610075097166 | Date13 Mar 2026 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number610075D01P014S012576 | Date16 Apr 2025 | StatusActive |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Hollister EUDAMEDAdapt GUDID
- Generic Name
- Peristomal/periwound dressing
- Device Name
- Ostomy Barrier Rings
- Model / Ref / Catalog
- 7815
- Primary DI / UDI-DI
- 00610075097166
- Basic UDI-DI
- 610075D01P014S012576
- Unit of Use DI
- 00610075097289
- FDA Product Code
- EXE
- EMDN Code
- A108001 Rings / bezels / plates for peristomal skin
- GMDN Term
- Peristomal/periwound dressing
- Device Class
- Class I
- Regulation Number
- 876.5900
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
- Size
- Width — 2.3 MillimeterOuter Diameter — 48 Millimeter
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 6ab24674-9b5f-4cd2-8e4f-7f3bd8fc1f49
- FDA UDI fe38fe57-4af1-4086-88fd-96ea53d0f9b8