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ß-THALASSAEMIA & HbA1c Assay Column(HPLC)
EUDAMEDClass C (EU MDR)
Ref 0320205Model H8, H9, H100
Identity
- Trade Name
- ß-THALASSAEMIA & HbA1c Assay Column(HPLC) EUDAMED
- Device Name
- ß-THALASSAEMIA & HbA1c Assay Column(HPLC) EUDAMED
- Model / Reference
- H8, H9, H100 EUDAMED0320205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139074596 EUDAMED
- Basic UDI-DI
- 6970341680120202GS EUDAMED
- EMDN Code
- W0201050280 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
ß-THALASSAEMIA & HbA1c Assay Column(HPLC) by Shenzhen Lifotronic Technology Co., Ltd. — Class C — 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 | 6970341680120202GS | Class C | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 67bac272-967a-426c-8e87-af0fbc28ea42 61 fields · synced Jun 19, 2026