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HiLIA 1250i
EUDAMEDClass A (EU MDR)
Ref CK-KR-BLOT-005Model HiLIA 1250i, HiLIA 1251i, HiLIA 1252i
Identity
- Trade Name
- HiLIA 1250i EUDAMED
- Device Name
- Fully Automatic Immunoblotting Analyser EUDAMED
- Model / Reference
- HiLIA 1250i, HiLIA 1251i, HiLIA 1252i EUDAMEDCK-KR-BLOT-005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926980315368 EUDAMED
- Basic UDI-DI
- 69269803YQHiLIA1250i3F EUDAMED
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
HiLIA 1250i by Guangzhou Kangrun Biotech Co., 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 | 69269803YQHiLIA1250i3F | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Kangrun Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000032267
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 6aed88ae-8ccb-4f07-8b12-69cb5ea77a01 61 fields · synced Jul 17, 2026