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Chromatographic Column(HPLC)
EUDAMEDClass IVD General (EU MDR)
Ref 0320215Model H100PlusModel GH-900Plus, H8, H9, H100, H100Plus
Identity
- Trade Name
- Chromatographic Column(HPLC) EUDAMED
- Device Name
- Chromatographic Column(HPLC) EUDAMED
- Model / Reference
- H100Plus EUDAMED0320215 EUDAMEDGH-900Plus, H8, H9, H100, H100Plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984062198 EUDAMED
- Basic UDI-DI
- B-06975984062198 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
- Germany 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-06975984062198 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975984062198 | 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 8bf7afe8-2c4b-4238-88e8-2623ac317076 61 fields · synced Jul 21, 2026
- EUDAMED 3143610e-ecd1-4afe-9005-f457b3a1a4ad 61 fields · synced May 19, 2026