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Glycated Hemoglobin （HbA1c）Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref R1: 1×60 mL, R2: 1×20 mL, Hemolytic agent: 2×70 mL
Identity
- Device Name
- Glycated Hemoglobin （HbA1c）Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 1×60 mL, R2: 1×20 mL, Hemolytic agent: 2×70 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974760129643 EUDAMED
- Basic UDI-DI
- B-06974760129643 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Glycated Hemoglobin （HbA1c）Assay Kit (Latex Immunoturbidimetric Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in…
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-06974760129643 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 4ac21758-36dd-4fd4-84c4-6258af6a95c6 61 fields · synced Oct 5, 2026
- EUDAMED 4ac21758-36dd-4fd4-84c4-6258af6a95c6-1 61 fields · synced Jun 9, 2026
- EUDAMED 4ac21758-36dd-4fd4-84c4-6258af6a95c6-2 61 fields · synced Jun 9, 2026