Evolis 89601
by Bio-Rad
Ref 89601
Evolis 89601 is a device classified as Class A in the EU and Class I in the US made by Bio-Rad, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 361052A000457R) and listed in FDA GUDID since 3 Feb 2023 (UDI-DI 03610520013328), active as of 24 Oct 2026.
Active
CE IVDR
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/IVDR EUDAMED | Number361052A000457R 03610520013328 | Date13 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number03610520013328 | Date3 Feb 2023 | StatusListed |
Official records
- EUDAMED public site 361052A000457R
- AccessGUDID record 03610520013328
Across registries
- EUDAMED Basic UDI-DI 361052A000457R registered 13 Oct 2026 Active
- FDA GUDID UDI-DI 03610520013328 listed 3 Feb 2023 Listed
Timeline
- Listed FDA GUDID 03610520013328
- Registered EUDAMED 361052A000457R
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Evolis
- Generic name
- Enzyme immunoassay (EIA) analyser IVD
- Device name
- Full Automated Microplate Analyzer
- Model / Ref / Catalog
- 89601
- Primary DI / UDI-DI
- 03610520013328
- Basic UDI-DI
- 361052A000457R
- FDA product code
- JJE
- EMDN code
- W0204 Infectious immunology instruments
- GMDN term
- Enzyme immunoassay (EIA) analyser IVD
- Device class
- Class A EUDAMEDClass I GUDID
- Regulation number
- 862.2160
- EU registration type
- Standard device
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class A | Class I |
Similar devices in this category
Other devices filed under INFECTIOUS IMMUNOLOGY INSTRUMENTS.