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Fe REAGENT KIT (FERENE METHOD)

EUDAMED

Class IVD General (EU MDR)

Ref 3002855Model R1: 2x50mL, R2: 1x20mLRef 3023238Model R1: 4x50mL, R2: 2x20mLRef 3023239Ref 3016508

by Dirui Industrial Co., Ltd

Identity

Trade Name
Fe REAGENT KIT (FERENE METHOD) EUDAMED
Device Name
Fe REAGENT KIT (FERENE METHOD) EUDAMED
Model / Reference
R1: 2x50mL, R2: 1x20mL EUDAMED
3002855 EUDAMED
R1: 4x50mL, R2: 2x20mL EUDAMED
3023238 EUDAMED
3023239 EUDAMED
3016508 EUDAMED

Identifiers

Primary DI / UDI-DI
06942202260469 EUDAMED
06942202213021 EUDAMED
06942202213038 EUDAMED
06942202260476 EUDAMED
Basic UDI-DI
B-06942202260469 EUDAMED
B-06942202213021 EUDAMED
B-06942202213038 EUDAMED
B-06942202260476 EUDAMED
EMDN Code
W01010216 IRON (CC) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Fe REAGENT KIT (FERENE METHOD) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Dirui Industrial Co., Ltd
EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (4)

  • EUDAMED a9643089-e85f-431b-b469-73a23f2ea9ca 61 fields · synced Jul 26, 2026
  • EUDAMED 0f2ec809-f6f9-400b-9e5e-d42303c56cb5 61 fields · synced Jul 10, 2026
  • EUDAMED 04d7cdee-7359-41a8-863d-4b8db3b67071 61 fields · synced Jul 13, 2026
  • EUDAMED 40d062c9-4cb2-4c7d-8c42-4ac102097a29 61 fields · synced Jul 26, 2026