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Fastep

EUDAMEDFDA 510(k)

Class IVD devices for self-testing (EU MDR)

Ref MI-S33001H5510(k) K233174

by Assure Tech. (Hangzhou) Co., Ltd.

Identity

Trade Name
Fastep EUDAMED
Device Name
COVID-19 & Influenza A/B Antigen Nasal Test Kit EUDAMED
Model / Reference
MI-S33001H5 EUDAMED

Identifiers

Primary DI / UDI-DI
16952804833715 EUDAMED
Basic UDI-DI
B-16952804833715 EUDAMED
510(k) Number
K233174 FDA 510(k)
FDA Product Code
LCX FDA 510(k)
EMDN Code
W0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1155 FDA 510(k)
Regulation Number
862.1155 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Fastep by Assure Tech. (hangzhou) Co., Ltd. — Class IVD devices for self-testing — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Assure Tech. (Hangzhou) Co., Ltd.
EUDAMED SRN
CN-MF-000002170
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (2)

  • EUDAMED be0b4233-a7c4-4c18-bfe2-2e1743833ec7 61 fields · synced Jul 21, 2026
  • FDA 510(k) K233174 24 fields · synced May 18, 2026