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QuikRead go HbA1c
EUDAMEDClass IVD General (EU MDR)
Ref 151058Ref 154520
by Aidian Oy
Identity
- Trade Name
- QuikRead go HbA1c EUDAMEDQuikRead go HbA1c Control Set EUDAMED
- Device Name
- QuikRead go HbA1c EUDAMEDQuikRead go HbA1c Control Set EUDAMED
- Model / Reference
- 151058 EUDAMED154520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438115001393 EUDAMED06438115001560 EUDAMED
- Basic UDI-DI
- B-06438115001393 EUDAMEDB-06438115001560 EUDAMED
- EMDN Code
- W0102160102 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC EUDAMEDW010302080501 HEMOSTASIS CONTROLS RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
QuikRead go HbA1c by Aidian Oy — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438115001393 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (2)
- EUDAMED e6d51906-7c1a-47e5-9d8a-d6b347888e3b 61 fields · synced Jul 20, 2026
- EUDAMED 72eb6fb9-44d9-45b8-be48-4df233b25d59 61 fields · synced May 17, 2026