Skip to content

Dental Clamp No. 00

by Mark One Surgical

Ref D-125-070Model RUBBER DAM INSTRUMENT

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 Number896110404RUBERINSCLASSI3B Basic UDI-DI 08961104042254UDI-DIDate21 May 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  • Withdrawn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

Device Name
IV Rubber Dam Instrument
Model / Reference
RUBBER DAM INSTRUMENT, D-125-070
Primary DI / UDI-DI
08961104042254
Basic UDI-DI
896110404RUBERINSCLASSI3B
EMDN Code
L15901102 Dam positioning instruments, reusable
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
PK-MF-000031202
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

Other devices from Mark One Surgical

See all devices from Mark One Surgical →

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