Alinity m
by Abbott Molecular Inc. 4 variants
Ref 08N50-070
Alinity m (08N50-070) is a Class D device made by Abbott Molecular, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI 0884999AMN0850XK), active as of 7 Nov 2026.
Active
CE IVDR
Valid until
26 Aug 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0884999AMN0850XK 00884999047174 | Date19 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 0884999AMN0850XK
Certificates
- IVDR 776722 Active
Technical documentation EU IVDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 27 Aug 2025
- Expires
- 26 Aug 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- Alinity M Hcv
- Model / reference
- 08N50-070
- Primary DI / UDI-DI
- 00884999047174
- Basic UDI-DI
- 0884999AMN0850XK
- EMDN code
- W0105020307 Hepatitis c virus - na reagents
- Device class
- Class D
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000017776
- Authorised representative
- Abbott GmbH DE-AR-000009457
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