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abSEQ™ Sequencing Set SE100 AppC

by AITbiotech Pte Ltd 2 variants

Ref 302013

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 Number888501971302013UA Basic UDI-DI 08885019711268UDI-DIDate21 Jul 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
abSEQ™ Sequencing Set SE100 AppC
Model / Reference
302013
Primary DI / UDI-DI
08885019711268
Basic UDI-DI
888501971302013UA
EMDN Code
W0105900103 Supplemental na reagents
Device Class
Class A
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 SEQ Detail

Other devices from AITbiotech Pte Ltd

See all devices from AITbiotech Pte Ltd →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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