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Brisk

by Qinhuangdao Primus Biotech Limited

Ref BRST-0, PUTTYModel BRST-0；BRST-1；BRST-2；BRST-3； BRST-0; BRST-1; BRST-2; BRST-3；or customied, PUTTY；FLUID；Silicone rubber for artificial gums；or customied

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 Number697734798BRSTX8 Basic UDI-DI Date16 Apr 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  • Withdrawn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
Elastomeric impression material
Silicone rubber replication material
Model / Reference
BRST-0；BRST-1；BRST-2；BRST-3； BRST-0, BRST-1, BRST-2, BRST-3；or customied, BRST-0, PUTTY；FLUID；Silicone rubber for artificial gums；or customied, PUTTY
Primary DI / UDI-DI
06977347980002, 16977347980153
Basic UDI-DI
697734798BRSTX8, 697734798GXJZM
EMDN Code
Q01020102, Q01020104
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041316
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Qinhuangdao Primus Biotech Limited

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