Spengler JT100 Control Solution (Level 2) (CE)

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref JT100

by Tyson Bioresearch, Inc.

Identity

Trade Name: Spengler JT100 Control Solution (Level 2) (CE) EUDAMED
Device Name: Spengler JT100 Control Solution (Level 2) (CE) EUDAMED
Model / Reference: JT100 EUDAMED

Identifiers

Primary DI / UDI-DI: 04719869705921 EUDAMED
Basic UDI-DI: B-04719869705921 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

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

Yes

EUDAMED

Spengler JT100 Control Solution (Level 2) (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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-04719869705921	Class IVD Annex II List B	Active

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Manufacturer

Manufacturer: Tyson Bioresearch, Inc.
EUDAMED SRN: TW-MF-000027508
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (1)

EUDAMED 864e61a4-042f-4f3f-9f67-6c5a130a47c9 61 fields · synced Jun 18, 2026