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abTES™ Atypical Pneumonia qPCR I Kit (100 Reactions)

by AITbiotech Pte Ltd

Ref 300276

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08885019710698 Basic UDI-DI 08885019710698UDI-DIDate19 Jun 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  • Withdrawn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
abTES™ Atypical Pneumonia qPCR I Kit (100 Reactions)
Model / Reference
300276
Primary DI / UDI-DI
08885019710698
Basic UDI-DI
B-08885019710698
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
SG-MF-000003510
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

From the manufacturer

Manufacturer's product page: Ab TES Atypical Pneumonia Detail

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See all devices from AITbiotech Pte Ltd →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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