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ß-THALASSAEMIA & HbA1c Assay Column (HPLC)
EUDAMEDClass IVD General (EU MDR)
Ref 0320208Model H9Ref 0320209Model H8Ref 032020602Model H8, H9, H100Ref 0320207
Identity
- Trade Name
- ß-THALASSAEMIA & HbA1c Assay Column (HPLC) EUDAMEDß-THALASSAEMIA & HbA1c Assay Column(HPLC) EUDAMED
- Device Name
- ß-THALASSAEMIA & HbA1c Assay Column (HPLC) EUDAMEDß-THALASSAEMIA & HbA1c Assay Column(HPLC) EUDAMED
- Model / Reference
- H9 EUDAMED0320208 EUDAMEDH8 EUDAMED0320209 EUDAMEDH8, H9, H100 EUDAMED032020602 EUDAMED0320207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341680046 EUDAMED06975984066356 EUDAMED06978139072653 EUDAMED06978139074619 EUDAMED
- Basic UDI-DI
- B-06970341680046 EUDAMEDB-06975984066356 EUDAMED6970341680120202GS EUDAMED
- EMDN Code
- W0201050201 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS EUDAMEDW0201050280 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
Yes
EUDAMEDEUDAMED
ß-THALASSAEMIA & HbA1c Assay Column (HPLC) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06970341680046 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06970341680046 | Class IVD General | 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 (4)
- EUDAMED 605dc89d-581b-4e55-9f18-4b08f9acacb0 61 fields · synced Sep 18, 2026
- EUDAMED 1e2a853b-7015-412f-b3c3-92701139a3d1 61 fields · synced May 17, 2026
- EUDAMED 20c31afe-bde7-4945-9d56-d861baa42da9 61 fields · synced May 18, 2026
- EUDAMED 4790ef5a-4dd4-4f6b-ae16-c34209897251 61 fields · synced May 19, 2026