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ASO/CRP/RF Ctrl H - ASO/PCR/RF CTRL H / ASO/CRP/RF CTRL H

by Sanymed s.a.s.

Ref TUS116

Active European Union

CE IVDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08056216739199 Basic UDI-DI 08056216739199UDI-DIDate16 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
ASO/CRP/RF Ctrl H - ASO/PCR/RF CTRL H / ASO/CRP/RF CTRL H MULTI-PURPOSE KIT CTL: 2x1mL (Lyophilized)
Model / Reference
TUS116
Primary DI / UDI-DI
08056216739199
Basic UDI-DI
B-08056216739199
EMDN Code
W01021110 Rheumatoid factors
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026483

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Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No