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better

by Beijing OKVD Biological Technology Ltd.

Ref AK-Y-1×400ml0Model AK-Y-1×200ml0 AK-Y-1×300ml0 AK-Y-1×400ml0 AK-Y-1×500ml0 AK-Y-1C×200ml0 AK-Y-1C×300ml0 AK-Y-1C×400ml0 AK-Y-1C×500ml0 AK-Y-2×25ml3 AK-Y-2C×25ml3 AK-Y-ATF×360ml3 AK-Y-ATF×380ml3 AK-Y-ATF×400ml3

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697704093VPSIM018U Basic UDI-DI 06977040930038UDI-DIDate4 Jan 2024RegisteredStatusActive

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  • Withdrawn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
VPS Impression Material
Model / Reference
AK-Y-1×200ml0 AK-Y-1×300ml0 AK-Y-1×400ml0 AK-Y-1×500ml0 AK-Y-1C×200ml0 AK-Y-1C×300ml0 AK-Y-1C×400ml0 AK-Y-1C×500ml0 AK-Y-2×25ml3 AK-Y-2C×25ml3 AK-Y-ATF×360ml3 AK-Y-ATF×380ml3 AK-Y-ATF×400ml3, AK-Y-1×400ml0
Primary DI / UDI-DI
06977040930038
Basic UDI-DI
697704093VPSIM018U
EMDN Code
Q01020101, Q01020102, Q01020103, Q01020104, Q01020199
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000039102
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Beijing OKVD Biological Technology 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