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Tiger

by Lead Dental Instruments Co. 87 variants

Ref OL 647TW

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 linked in EUDAMED

A group certificate may exist

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 Number8964004046OL647TWGA Basic UDI-DI 08964003881603UDI-DIDate6 Jul 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Debonding Tweezer with Positioning Blade
Model / Reference
OL 647TW
Primary DI / UDI-DI
08964003881603
Basic UDI-DI
8964004046OL647TWGA
Direct Marketing DI
08964003881603
EMDN Code
L150799 Orthodontic instruments, reusable - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
PK-MF-000029995
Authorised representative
KHANG BAO INTERNATIONAL KFT HU-AR-000034102

Other devices from Lead Dental Instruments Co.

See all devices from Lead Dental Instruments Co. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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