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Tandem AI Medical Coder

by Tandem Health AB

Ref 2

Active European Union

CE MDR

Valid until

15 Feb 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Scarlet NB B.V.

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/MDR NumberSCAR-9.2.1.7 Date16 Sep 2026IssuedStatusActive expires 15 Feb 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-9.2.1.7 Active Amended

    Quality management system EU MDR

    Certifier
    Scarlet NB B.V. 3022
    Issued
    16 Sep 2026
    Expires
    15 Feb 2031
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Tandem AI Medical Coder
Model / Reference
2
Primary DI / UDI-DI
07350179820019
Basic UDI-DI
735017982TANDEMCODER53
Direct Marketing DI
07350179820019
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000049463

Other devices from Tandem Health AB

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No