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Glycated Hemoglobin A1c (HbA1c) Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.06.03.EC.01
by Zybio Inc.
Identity
- Device Name
- Glycated Hemoglobin A1c (HbA1c) Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 01.09.06.03.EC.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967223450 EUDAMED
- Basic UDI-DI
- B-06941967223450 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Glycated Hemoglobin A1c (HbA1c) Kit (Immunoturbidimetric Method) by Zybio Inc. — 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-06941967223450 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 23c482da-18c6-4c07-b03a-069310128854 61 fields · synced Jul 30, 2026