Identity
- Trade Name
- HBA1C DİREKT KİTİ EUDAMED
- Device Name
- HBA1C DIRECT REAGENT EUDAMED
- Model / Reference
- 01R87-41 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699015281683 EUDAMED
- Basic UDI-DI
- B-08699015281683 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Hba1c Di̇rekt Ki̇ti̇ by Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — 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-08699015281683 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000027166
Sources (1)
- EUDAMED 402aad10-3921-49ca-867e-e3197bae1801 61 fields · synced Oct 7, 2026