← Back to catalogue

Uric Acid Monitoring Test Strips

EUDAMED

Class IVD devices for self-testing (EU MDR)

Ref US-101

by Sejoy Biomedical Co., Ltd.

Identity

Trade Name
Uric Acid Monitoring Test Strips EUDAMED
Device Name
Uric Acid Monitoring Test Strips EUDAMED
Model / Reference
US-101 EUDAMED

Identifiers

Primary DI / UDI-DI
06939663975056 EUDAMED
Basic UDI-DI
B-06939663975056 EUDAMED
EMDN Code
W01010232 URIC ACID EUDAMED

Classification

Device Class
Class IVD devices for self-testing EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Uric acid IVD, reagent

Uric Acid Monitoring Test Strips by Sejoy Biomedical Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Uric acid IVD, reagent.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sejoy Biomedical Co., Ltd.
EUDAMED SRN
CN-MF-000008447
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 92f13639-0524-4019-9efb-df33c1fb0a7a 61 fields · synced Jun 19, 2026