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by Fujian Secure Medical Technology CO., Ltd. 93 variants

Ref G-0B1-00-JS4Model G-0B1-00, G-0B2-00, G-0DZ-00, G-0B1-00-BS, G-0B1-00-HWKS2, G-0B2-00-DYH, G-0B2-00-DYH1, G-0B-00-0PMD2, G-0B1-00-JS3, G-0B1-00-JS4,G-0B1-00-AK2

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697327837MobileC04SU Basic UDI-DI 06973278371537UDI-DIDate6 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
G-0B1-00, G-0B2-00, G-0DZ-00, G-0B1-00-BS, G-0B1-00-HWKS2, G-0B2-00-DYH, G-0B2-00-DYH1, G-0B-00-0PMD2, G-0B1-00-JS3, G-0B1-00-JS4, G-0B1-00-AK2
Primary DI / UDI-DI
06973278371537
Basic UDI-DI
697327837MobileC04SU
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000009726
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

Other devices from Fujian Secure Medical Technology CO., Ltd.

See all devices from Fujian Secure Medical Technology 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