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Chromatographic Column(HPLC)
EUDAMEDClass IVD General (EU MDR)
Ref 0320206Model H9Model GH-900Plus, H8, H9, H100, H100Plus
Identity
- Trade Name
- Chromatographic Column(HPLC) EUDAMED
- Device Name
- Chromatographic Column(HPLC) EUDAMED
- Model / Reference
- H9 EUDAMED0320206 EUDAMEDGH-900Plus, H8, H9, H100, H100Plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062174 EUDAMED
- Basic UDI-DI
- B-06975984062174 EUDAMED6970341680120201GQ EUDAMED
- EMDN Code
- W0201050280 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Italy EUDAMEDGermany 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
Chromatographic Column(HPLC) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975984062174 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975984062174 | 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 (2)
- EUDAMED 7317d840-b98f-4763-8f09-f876d1c5929a 61 fields · synced Jul 9, 2026
- EUDAMED 41890c93-1287-4aa2-8976-8c9543d5607c 61 fields · synced May 19, 2026