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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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  • MD Atlas
  • Zhejiang Orient Gene Biotech Co., Ltd

Data from EUDAMED, last updated Jun 11, 2026

Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)

B-GCZIK(IgG/IgM)-T402a3U

1 reference

IVDD — General
Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — General
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd

Device family identification

Device name
Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)
Basic UDI-DI
B-GCZIK(IgG/IgM)-T402a3U
Device model
GCZIK(IgG/IgM)-T402a
Issuing agency
EUDAMED
Version date
May 12, 2026

Classification

Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — General
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Zhejiang Orient Gene Biotech Co., Ltd
SRN
CN-MF-000017965
Country
China
Email
joyce.pang@orientgene.com

Authorised representative

Name
CMC Medical Devices & Drugs SL
SRN
ES-AR-000000293
Country
Spain
Phone
+34951214054

Device characteristics

ReagentProfessional testingAnimal tissues / cells

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • W0105040630Zika virus

References by status

Clinical investigations

Investigation number
TF- ZIK(IgG/IgM) -B
Registered
No
Countries
China

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KRD00PA3SK8C9VM3EFB4YRDF

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)GCZIK(IgG/IgM)-T402aD-GCZIK(IgG/IgM)-T402a3U1On the market