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ASO Fast Test Kit (Immunofluorescence Assay)

EUDAMED

Class B (EU MDR)

Ref IF1076Ref IF2076Ref /

by Getein Biotech, Inc.

Identity

Trade Name
ASO Fast Test Kit (Immunofluorescence Assay) EUDAMED
Device Name
ASO Fast Test Kit (Immunofluorescence Assay) EUDAMED
Model / Reference
IF1076 EUDAMED
IF2076 EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06954414724899 EUDAMED
06954414724912 EUDAMED
06954414702644 EUDAMED
Basic UDI-DI
695441470264HG EUDAMED
B-06954414702644 EUDAMED
EMDN Code
W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMED

Classification

Device Class
Class B EUDAMED
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED
Belgium EUDAMED
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

Microbial Substances

Yes

EUDAMEDEUDAMED

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

ASO Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Getein Biotech, Inc.
EUDAMED SRN
CN-MF-000017986
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (3)

  • EUDAMED cb49e42e-a796-40db-862f-3c61e58f5b42 61 fields · synced Aug 2, 2026
  • EUDAMED 037ac6aa-e4f9-40b3-88bb-75987f9f799c 61 fields · synced May 17, 2026
  • EUDAMED 553cf0c3-a1e8-4409-a687-19fa1dcda315 61 fields · synced May 18, 2026