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Aldolase And Glutathione Reductase Calibrator (als & Glut Red Cal)
EUDAMEDClass B (EU MDR)
Ref AGR10571
Identity
- Trade Name
- ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS & GLUT RED CAL) EUDAMED
- Device Name
- ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS & GLUT RED CAL) EUDAMED
- Model / Reference
- AGR10571 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055273218831 EUDAMED
- Basic UDI-DI
- 50552732BAGRCAL1565X EUDAMED
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Aldolase And Glutathione Reductase Calibrator (als & Glut Red Cal) by Randox Laboratories Limited — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50552732BAGRCAL1565X | Class B | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (1)
- EUDAMED 2cce151f-7327-4aaa-92a3-c390861dae8c 61 fields · synced Oct 5, 2026