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High Speed Centrifuge

EUDAMED

Class A (EU MDR)

Ref CFG-15DRef CFG-16D

by Infitek Co., Ltd.

Identity

Trade Name
High Speed Centrifuge EUDAMED
Device Name
Centrifuge EUDAMED
Model / Reference
CFG-15D EUDAMED
CFG-16D EUDAMED

Identifiers

Primary DI / UDI-DI
06975488441000 EUDAMED
06975488440393 EUDAMED
Basic UDI-DI
697548844CFG22ML EUDAMED
Direct Marketing DI
06975488440393 EUDAMED
EMDN Code
W02069003 CENTRIFUGES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Spain 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

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

High Speed Centrifuge by Infitek Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Infitek Co., Ltd.
EUDAMED SRN
CN-MF-000040107
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (2)

  • EUDAMED 2afecf28-2efe-4163-9cad-d0fb12fe8b92 61 fields · synced Jul 18, 2026
  • EUDAMED de131303-2f59-4266-9982-30acbc42f30d 61 fields · synced May 18, 2026