Identity
- Trade Name
- HbA1c ΔΙΑΛΥΜΑ ΑΙΜΟΛΥΣΗΣ 1x100 ml EUDAMED
- Device Name
- DILUTING SOLUTION EUDAMED
- Model / Reference
- 001781 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05213003193043 EUDAMED
- Basic UDI-DI
- 521300319DILUENV9 EUDAMED
- Direct Marketing DI
- 05213003193043 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece 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
New Device
No
EUDAMED
HbA1c ΔΙΑΛΥΜΑ ΑΙΜΟΛΥΣΗΣ 1x100 ml by Biotechnological Applications Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 521300319DILUENV9 | Class A | Active |
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Manufacturer
- Manufacturer
- Biotechnological Applications Ltd
- EUDAMED SRN
- GR-MF-000033000
Sources (1)
- EUDAMED f8de5949-15b5-40fe-8ed5-c173daf834e5 61 fields · synced Aug 4, 2026