Lipase, R1 4 x 10 mL, R2 1 x 8 mL, CAL 1 x 1 mL

EUDAMED

Class IVD General (EU MDR)

Ref 101-0410

by Chronolab Systems, S.L.

Identity

Trade Name: Lipase, R1 4 x 10 mL, R2 1 x 8 mL, CAL 1 x 1 mL EUDAMED
Device Name: Lipase, R1 4 x 10 mL, R2 1 x 8 mL, CAL 1 x 1 mL EUDAMED
Model / Reference: 101-0410 EUDAMED

Identifiers

Primary DI / UDI-DI: D-084360386276279H3 EUDAMED
Basic UDI-DI: B-084360386276279H3 EUDAMED
EMDN Code: W01010123 LIPASE EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Lipase, R1 4 x 10 mL, R2 1 x 8 mL, CAL 1 x 1 mL by Chronolab Systems, S.L. — Class IVD General — 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-084360386276279H3	Class IVD General	Active

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Manufacturer

Manufacturer: Chronolab Systems, S.L.
EUDAMED SRN: ES-MF-000017043

Sources (1)

EUDAMED c4b83816-9228-4a6e-9278-72f45b778006 61 fields · synced Oct 6, 2026