urien reagent package

Ref /Model Cleanser I: 500mL, 1L, 2L, 4L, 5L, 10L, 20L; Cleanser II: 40mL, 50mL, 100mL, 120mL, 150mL, 200mL, 250mL, 300mL, 400mL, 500mL, 800mL; Buffer: 40mL, 50mL, 100mL, 120mL, 150mL, 200mL, 250mL, 300mL, 400mL, 500mL, 800mL.

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69560139RKUFEAnalyzer85 Basic UDI-DI 06956013910383UDI-DI	Date22 Jun 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference: Cleanser I: 500mL, 1L, 2L, 4L, 5L, 10L, 20L, Cleanser II: 40mL, 50mL, 100mL, 120mL, 150mL, 200mL, 250mL, 300mL, 400mL, 500mL, 800mL, Buffer: 40mL, 800mL., /

Primary DI / UDI-DI: 06956013910383
Basic UDI-DI: 69560139RKUFEAnalyzer85
EMDN Code: W01019099 Clinical chemistry reagents - other

Device Class: Class A
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000031214
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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IVD General

Properties

Other properties (11)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Reagent: No
Self Testing: No
Near-Patient Testing: No
Professional Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No