C-reactive protein (CRP), 5 mL Latex, 1 mL positive Control, 1 mL negative cont…

EUDAMED

Class IVD General (EU MDR)

Ref 101-0217

by Chronolab Systems, S.L.

Identity

Trade Name: C-reactive protein (CRP), 5 mL Latex, 1 mL positive Control, 1 mL negative control EUDAMED
Device Name: C-reactive protein (CRP), 5 mL Latex, 1 mL positive Control, 1 mL negative control EUDAMED
Model / Reference: 101-0217 EUDAMED

Identifiers

Primary DI / UDI-DI: D-084360385645646H3 EUDAMED
Basic UDI-DI: B-084360385645646H3 EUDAMED
EMDN Code: W01021109 C-REACTIVE PROTEIN EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

C-reactive protein (CRP), 5 mL Latex, 1 mL positive Control, 1 mL negative cont… by Chronolab Systems, S.L. — Class IVD General — IVDD — listed in EUDAMED

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-084360385645646H3	Class IVD General	Active

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

Manufacturer

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

Sources (1)

EUDAMED 9af2a731-6dd0-462b-9b69-e3733321c85c 61 fields · synced Jun 19, 2026