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HEMOGLOBIN A1C-DIRECT (HbA1C-DIR)
EUDAMEDClass IVD General (EU MDR)
Ref 31047Ref 22147Ref 22047Ref 13047
Identity
- Device Name
- HEMOGLOBIN A1C-DIRECT (HbA1C-DIR) EUDAMED
- Model / Reference
- 31047 EUDAMED22147 EUDAMED22047 EUDAMED13047 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287100952 EUDAMED08435287102444 EUDAMED08435287100976 EUDAMED08435287100969 EUDAMED
- Basic UDI-DI
- B-08435287100952 EUDAMEDB-08435287102444 EUDAMEDB-08435287100976 EUDAMEDB-08435287100969 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
HEMOGLOBIN A1C-DIRECT (HbA1C-DIR) by Biosystems S.a. — 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-08435287100952 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (4)
- EUDAMED 5bb1c9ff-604d-48e2-8fb1-a02b929ea365 61 fields · synced Jul 28, 2026
- EUDAMED 6e4cbaaf-ed1a-4d9f-958d-b286a5e67591 61 fields · synced May 17, 2026
- EUDAMED 9603846b-d440-4561-aadf-a2d961bab75c 61 fields · synced May 17, 2026
- EUDAMED 530d2ff2-f143-493a-84d1-5ae4ef247e6d 61 fields · synced May 18, 2026