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Uni-medica

by Shenzhen Uni-medica Technology Co., Ltd. 17 variants

Ref 15.09.002.02Model NFAST 96, NFAST 32A

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

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697456152NFAST32ABE Basic UDI-DI 06974561520113UDI-DIDate13 Aug 2022RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Nucleic Acid Extractor
Model / Reference
NFAST 96, NFAST 32A, 15.09.002.02
Primary DI / UDI-DI
06974561520113
Basic UDI-DI
697456152NFAST32ABE
Direct Marketing DI
06974561520113
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class A
Special Device Type
Software
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000022946
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Related devices

Category: Nucleic acid sample preparation instrument IVD

Other devices from Shenzhen Uni-medica Technology Co., Ltd.

See all devices from Shenzhen Uni-medica Technology Co., Ltd. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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