Axis-Shield
by Axis-Shield Diagnostics Ltd 6 variants
Ref 2R10-02
Axis-Shield (2R10-02) is an in vitro diagnostic device (EU IVDR Class C; EMDN category cardiac marker standards and calibrators) made by Axis-Shield Diagnostics Limited, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 50558454NTP0010M4), active as of 24 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number50558454NTP0010M4 05055845400510 | Date20 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 50558454NTP0010M4
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- Alere NT-proBNP for ARCHITECT Calibrator Kit
- Model / reference
- 2R10-02
- Primary DI / UDI-DI
- 05055845400510
- Basic UDI-DI
- 50558454NTP0010M4
- EMDN code
- W0102152204 Cardiac marker standards and calibrators
- Device class
- Class C
- EU registration type
- Standard device
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000001886
- Authorised representative
- Abbott Rapid Dx International Limited IE-AR-000000091
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