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Chromatographic Column(HPLC)

EUDAMED

Class IVD General (EU MDR)

Ref 0320214Model H100Model GH-900Plus, H8, H9, H100, H100Plus

by Shenzhen Lifotronic Technology Co., Ltd.

Identity

Trade Name
Chromatographic Column(HPLC) EUDAMED
Device Name
Chromatographic Column(HPLC) EUDAMED
Model / Reference
H100 EUDAMED
0320214 EUDAMED
GH-900Plus, H8, H9, H100, H100Plus EUDAMED

Identifiers

Primary DI / UDI-DI
06975984062181 EUDAMED
Basic UDI-DI
B-06975984062181 EUDAMED
6970341680120201GQ EUDAMED
EMDN Code
W020105010280 LIMITED PANEL ELECTROPHORESIS ANALYSERS - HARDWARE ACCESSORIES EUDAMED
W0201050280 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Class C EUDAMED
Market of Registration
Italy EUDAMED
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

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Manufacturer

EUDAMED SRN
CN-MF-000005654
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 91b92d38-8b82-4035-b7de-43980f405ac6 61 fields · synced Jul 26, 2026
  • EUDAMED 73f3b73d-c580-40e4-af36-84406057ac0c 61 fields · synced May 18, 2026