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Copper Kit (Colorimetric Method with PAESA)

EUDAMED

Class IVD General (EU MDR)

Ref MJ307YModel 50mL(R1:1×40mL+R2:1×10mL);Calibrator:1×1mL

by MedicalSystem Biotechnology Co., Ltd.

Identity

Trade Name: Copper Kit (Colorimetric Method with PAESA) EUDAMED
Device Name: Copper Kit (Colorimetric Method with PAESA) EUDAMED
Model / Reference: 50mL(R1:1×40mL+R2:1×10mL);Calibrator:1×1mL EUDAMED
MJ307Y EUDAMED

Identifiers

Primary DI / UDI-DI: 06936595750164 EUDAMED
Basic UDI-DI: B-06936595750164 EUDAMED
EMDN Code: W01010206 COPPER EUDAMED

Classification

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

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Copper IVD, reagent

Copper Kit (Colorimetric Method with PAESA) by Medicalsystem Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Copper IVD, reagent.

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Copper Colorimetric Test with Dibromo-PAESA — Kalians Corporation · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Copper - Single reagent — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
EUDAMED SRN: CN-MF-000010246
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (1)

EUDAMED 39e33c40-08aa-47a4-8804-d67b3985ef13 61 fields · synced Jun 18, 2026