SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Met…

EUDAMED

Class IVD General (EU MDR)

Ref HWTS-RT170AModel 1 test/kitRef HWTS-RT170BModel 20 tests/kit

by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Identity

Trade Name: SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method) EUDAMED
Device Name: SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Method) EUDAMED
Model / Reference: 1 test/kit EUDAMED
HWTS-RT170A EUDAMED
20 tests/kit EUDAMED
HWTS-RT170B EUDAMED

Identifiers

Primary DI / UDI-DI: D-000012807183107QB EUDAMED
D-000012807183262QQ EUDAMED
Basic UDI-DI: B-000012807183107QB EUDAMED
B-000012807183262QQ EUDAMED
EMDN Code: W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

SARS-CoV-2, Flu A&B Antigen, RSV, ADV, and MP Combined Detection Kit (Latex Met… by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-000012807183107QB	Class IVD General	Active

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Manufacturer

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
EUDAMED SRN: CN-MF-000012807
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED d3a66a38-84c1-47b9-b531-db7f17e7111b 61 fields · synced Jul 15, 2026
EUDAMED f17b136e-f2be-4a50-9dba-24e779c4f74a 61 fields · synced May 18, 2026