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Glycosylated Hemoglobin (HbA1c) (Ion Exchange)
EUDAMEDClass IVD General (EU MDR)
Ref D-659 002
Identity
- Trade Name
- Glycosylated Hemoglobin (HbA1c) (Ion Exchange) EUDAMED
- Device Name
- Glycosylated Hemoglobin (HbA1c) (Ion Exchange) EUDAMED
- Model / Reference
- D-659 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182715434 EUDAMED
- Basic UDI-DI
- B-62230182715434 EUDAMED
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Glycosylated Hemoglobin (HbA1c) (Ion Exchange) by Kalians Corporation — 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-62230182715434 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 6d9ca787-2e47-4e2d-8d37-2a33a22f9ca2 61 fields · synced Jun 19, 2026