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Testing pack

EUDAMED

Class A (EU MDR)

Ref A060037Model 1 Tests/KitRef A060035Ref A060033Ref A060036Ref A060030

by Shenzhen Zijian Biotechnology Co., Ltd

Identity

Trade Name
Testing pack EUDAMED
Device Name
Testing pack EUDAMED
Model / Reference
1 Tests/Kit EUDAMED
A060037 EUDAMED
A060035 EUDAMED
A060033 EUDAMED
A060036 EUDAMED
A060030 EUDAMED

Identifiers

Primary DI / UDI-DI
06974674897058 EUDAMED
06974674897034 EUDAMED
06974674897010 EUDAMED
06974674897041 EUDAMED
06974674896983 EUDAMED
Basic UDI-DI
69746748900192A4 EUDAMED
EMDN Code
W0103010199 REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER 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

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Testing pack by Shenzhen Zijian Biotechnology 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
Shenzhen Zijian Biotechnology Co., Ltd
EUDAMED SRN
CN-MF-000022829
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (5)

  • EUDAMED 76d0fdab-c592-41fa-a3aa-755d3017a9a7 61 fields · synced Oct 6, 2026
  • EUDAMED 6c2e0dde-acb6-45e8-bf0f-dd1c84d73738 61 fields · synced May 17, 2026
  • EUDAMED 4c214d08-4736-4c07-99f8-03feee37c9f2 61 fields · synced May 18, 2026
  • EUDAMED 82d18729-5a37-432e-9564-15db734c7d16 61 fields · synced May 18, 2026
  • EUDAMED 50401a6a-1997-455f-8426-7f13636a3355 61 fields · synced May 19, 2026