Olympus WA23080A
Ref WA23080A
Olympus WA23080A is an invasive medical device leak tester (EU MDR Class I; FDA Class I; FDA product code FFY, Adaptor, Bulbs, Miscellaneous, For Endoscope) made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI 4042761110204J) and listed in FDA GUDID since 20 Jun 2023 (UDI-DI 04042761082280), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number4042761110204J 04042761082280 | Date19 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04042761082280 | Date20 Jun 2023 | StatusListed |
Official records
- EUDAMED public site 4042761110204J
- AccessGUDID record 04042761082280
Across registries
- EUDAMED Basic UDI-DI 4042761110204J registered 19 Jun 2026 Active
- FDA GUDID UDI-DI 04042761082280 listed 20 Jun 2023 Listed
Timeline
- Listed FDA GUDID 04042761082280
- Registered EUDAMED 4042761110204J
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Leakage tester, for flexible Olympus endoscopes EUDAMEDOlympus GUDID
- Generic name
- Invasive medical device leak tester, mechanical
- Device name
- Leakage Tester
- Model / reference
- WA23080A
- Primary DI / UDI-DI
- 04042761082280
- Basic UDI-DI
- 4042761110204J
- Direct marketing DI
- 04042761082280
- FDA product code
- FFY
- EMDN code
- Z12011380 Cleaning, disinfection and sterilisation instruments - hardware accessories
- GMDN term
- Invasive medical device leak tester, mechanical
- Device class
- Class I
- Regulation number
- 876.1500
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - HARDWARE ACCESSORIES.