Skip to content

Tencent AIMIS Digital Pathology Platform

by Tencent Healthcare (Changsha) Co., Ltd. 2 variants

Ref 001Model PATH-PACS-01

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697501005PATH01CG Basic UDI-DI 06975010050014UDI-DIDate7 Feb 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  • Withdrawn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

Model / Reference
PATH-PACS-01, 001
Primary DI / UDI-DI
06975010050014
Basic UDI-DI
697501005PATH01CG
Direct Marketing DI
06975010050014
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
Special Device Type
Software
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000019438
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Tencent Healthcare (Changsha) Co., Ltd.

Properties

  • Professional Testing
  • New Device

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
  • Surgical Instrument: No