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Chromatographic Column(HPLC)
EUDAMEDClass C (EU MDR)
Ref 0320207Model GH-900Plus, H8, H9, H100, H100PlusModel H8
Identity
- Trade Name
- Chromatographic Column(HPLC) EUDAMED
- Device Name
- Chromatographic Column(HPLC) EUDAMED
- Model / Reference
- GH-900Plus, H8, H9, H100, H100Plus EUDAMED0320207 EUDAMEDH8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062167 EUDAMED
- Basic UDI-DI
- 6970341680120201GQ EUDAMEDB-06975984062167 EUDAMED
- EMDN Code
- W0201050280 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDItaly 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 C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6970341680120201GQ | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 6970341680120201GQ | 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 (2)
- EUDAMED e44e9ab8-1832-4a4d-ae98-7f7646ca21f9 61 fields · synced Jul 13, 2026
- EUDAMED 51e621ff-f0cd-49bc-a4f0-44fe50a52227 61 fields · synced May 18, 2026