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Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)

EUDAMED

Class IVD General (EU MDR)

Ref 18-02-0033Model 50 Tests/kitRef 18-02-0032Model 25 Tests/kitRef 18-02-0034Model 100 Tests/kit

by Shenzhen Zijian Biotechnology Co., Ltd

Identity

Trade Name
Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method) EUDAMED
Device Name
Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method) EUDAMED
Model / Reference
50 Tests/kit EUDAMED
18-02-0033 EUDAMED
25 Tests/kit EUDAMED
18-02-0032 EUDAMED
100 Tests/kit EUDAMED
18-02-0034 EUDAMED

Identifiers

Primary DI / UDI-DI
06974674891414 EUDAMED
06974674891407 EUDAMED
06974674891421 EUDAMED
Basic UDI-DI
B-06974674891414 EUDAMED
B-06974674891407 EUDAMED
B-06974674891421 EUDAMED
EMDN Code
W0105090399 RETROVIRUSES - RT & POC - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMEDEUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method) by Shenzhen Zijian Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shenzhen Zijian Biotechnology Co., Ltd
EUDAMED SRN
CN-MF-000022829
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (3)

  • EUDAMED 11f6d9e1-1cae-4997-b7de-51b70cc094d5 61 fields · synced Oct 6, 2026
  • EUDAMED d115054c-9d03-48c8-a8bb-108f7f0376ad 61 fields · synced May 16, 2026
  • EUDAMED 530af740-5ff4-4ef4-98ac-e64c8ec4fdbc 61 fields · synced May 17, 2026