Skip to content

Sanity

by Guangdong Transtek Medical Electronics Co., Ltd. 3 variants

Ref AC2242-17Model AC2242-10

Active European Union

CE MDR

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/MDR Number69328253CUFFTV Basic UDI-DI 06932825303476UDI-DIDate5 Mar 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Cuff
Model / Reference
AC2242-10, AC2242-17
Primary DI / UDI-DI
06932825303476
Basic UDI-DI
69328253CUFFTV
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000010684
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Guangdong Transtek Medical Electronics Co., Ltd

See all devices from Guangdong Transtek Medical Electronics Co., Ltd →

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