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JS100 Blood Glucose Test Strips (50T) (CE)

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref JS100

by Tyson Bioresearch, Inc.

Identity

Trade Name
JS100 Blood Glucose Test Strips (50T) (CE) EUDAMED
Device Name
JS100 Blood Glucose Test Strips (50T) (CE) EUDAMED
Model / Reference
JS100 EUDAMED

Identifiers

Primary DI / UDI-DI
04719869704153 EUDAMED
Basic UDI-DI
B-04719869704153 EUDAMED
EMDN Code
W0201060102 BLOOD GLUCOSE METERS EUDAMED

Classification

Device Class
Class IVD Annex II List B EUDAMED
Market of Registration
France 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

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

JS100 Blood Glucose Test Strips (50T) (CE) by Tyson Bioresearch, Inc. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
TW-MF-000027508
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1)

  • EUDAMED a20ca886-3b2e-44bf-8d79-0327888c24bd 61 fields · synced Jul 8, 2026