RealTime
by Abbott Molecular Inc. 8 variants
Ref 02G31-010
RealTime (02G31-010) is a Class D device made by Abbott Molecular, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 0884999RTG00017G), active as of 7 Nov 2026.
Active
CE IVDR
Valid until
15 Jul 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number0884999RTG00017G 00884999045088 | Date19 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 0884999RTG00017G
Certificates
- IVDR 798927 Active
Technical documentation EU IVDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 19 Mar 2025
- Expires
- 15 Jul 2029
- Valid from
- 1 May 2025
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- Abbott Realtime Hiv-1
- Model / reference
- 02G31-010
- Primary DI / UDI-DI
- 00884999045088
- Basic UDI-DI
- 0884999RTG00017G
- EMDN code
- W0105030107 HIV 1 - 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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