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Copper Colorimetric Test with Dibromo-PAESA

EUDAMED

Class IVD General (EU MDR)

Ref D-617 003

by Kalians Corporation

Identity

Trade Name
Copper Colorimetric Test with Dibromo-PAESA EUDAMED
Device Name
Copper Colorimetric Test with Dibromo-PAESA EUDAMED
Model / Reference
D-617 003 EUDAMED

Identifiers

Primary DI / UDI-DI
62230182712600 EUDAMED
Basic UDI-DI
B-62230182712600 EUDAMED
EMDN Code
W01010206 COPPER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany 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

Category: Copper IVD, reagent

Copper Colorimetric Test with Dibromo-PAESA by Kalians Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Copper IVD, reagent.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Kalians Corporation
EUDAMED SRN
EG-MF-000050142
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1)

  • EUDAMED 293e9af9-9c98-4db8-ac9d-747162fc48ef 61 fields · synced Jun 18, 2026