Hollister
by Hollister Incorporated United States EUDAMEDGUDID
Ref 72144
Product code GBMEMDN U01010501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number610075D03P081S0258C4 | Date28 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00610075081257 | Date30 Sep 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Hollister EUDAMEDVaPro GUDID
- Generic Name
- Single-administration urethral drainage catheter
- Model / Ref / Catalog
- 72144
- Primary DI / UDI-DI
- 00610075081257, 00610075092642
- Basic UDI-DI
- 610075D03P081S0258C4, 610075D03P092S0368DA
- Unit of Use DI
- 00610075065448, 20610075092646
- FDA Product Code
- GBM
- EMDN Code
- U01010501 Nelaton catheters, self-lubricating
- GMDN Term
- Single-administration urethral drainage catheter
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 876.5130
- Market of Registration
- Ireland
- Commercial Distribution
- In Commercial Distribution
- Size
- Length — 16 InchCatheter Gauge — 14 FrenchLength — 40 Centimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
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 (18)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (4)
- EUDAMED 28ba68ab-e777-40ee-ba0a-474e1352e8b5
- FDA UDI 7db21b24-1eb9-4844-99cc-eb4b74f338b8
- FDA UDI 1d75c333-310b-4c2b-ae16-d179396401c8
- EUDAMED 00610075092642|610075D03P092S0368DA