Hollister
by Hollister Incorporated United States EUDAMEDGUDID
Ref 7740
Product code EXBEMDN A100399
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number610075D01P060S01848P | Date16 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00610075123254 | Date1 Dec 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Hollister EUDAMEDAdapt GUDID
- Generic Name
- General-body orifice lubricant
- Model / Ref / Catalog
- 7740
- Primary DI / UDI-DI
- 00610075123254 EUDAMED00610075077403 GUDID
- Basic UDI-DI
- 610075D01P060S01848P
- FDA Product Code
- EXB
- EMDN Code
- A100399 Abdominal ostomy irrigation devices - other
- GMDN Term
- General-body orifice lubricant
- Device Class
- Class I
- Regulation Number
- 876.5900
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 00610075123254 | 00610075077403 |
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 (20)
- Sterile: No
- Single Use: 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 b643c16e-1b20-4c06-a2b1-8985ccc0913c
- FDA UDI ba597580-7623-4c7b-9c34-971e1b24c1e0