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Round

by Tek Metal Sanayi ve Ticaret A.Ş. 58 variants

Ref FG 801-033 C STD, FG 801-029 F STD, FG 801-029 G STD, FG 801-014 H XL, FG 801-025 G STD, FG 801-021 H STD, FG 801-027 H STD, FG 801-018 H L, FG 801-012 C STD, FG 801-014 H L, FG 801-023 STD, FG 801-009 C STD, FG 801-010 STD, FG 801-023 G XL, FG 801-023 F STD, FG 802-014 STD, FG 801-042 F STD, FG 801-027 F STD, FG 801-012 STD, FG 801-010 U STD, FG 801-021 F STD, FG 801-010 G STD, FG 801-016 L, FG 801-014 C STD, FG 801-016 G L, FG 801-012 SHORT, FG 801-035 F STD, FG 801-018 XL, FG 801-014 F STD, FG 801-009 STD, FG 801-014 SHORT, FG 801-010 C STD, FG 801-008 STD, FG 801-010 F STD, FG 801-023 G STD, FG 801-027 G STD, FG 801-010 XL, FG 802-021 STD, FG 801-018 F STD, FG 801-014 G XL, FG 801-009 G STD, FG 801-009 F STD, FG 802-016 G STD, FG 801-010 SHORT, FG 801-033 F STD, FG 801-016 F STD, FG 801-033 STD, FG 802-012 G STD, FG 801-018 G STD, FG 801-027 STD, FG 801-016 XL

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86994018TMTP0177 Basic UDI-DI Date5 Mar 2026RegisteredStatusActive

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  • Withdrawn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
Round
Model / Reference
FG 801-033 C STD, FG 801-029 F STD, FG 801-029 G STD, FG 801-014 H XL, FG 801-025 G STD, FG 801-021 H STD, FG 801-027 H STD, FG 801-018 H L, FG 801-012 C STD, FG 801-014 H L, FG 801-023 STD, FG 801-009 C STD, FG 801-010 STD, FG 801-023 G XL, FG 801-023 F STD, FG 802-014 STD, FG 801-042 F STD, FG 801-027 F STD, FG 801-012 STD, FG 801-010 U STD, FG 801-021 F STD, FG 801-010 G STD, FG 801-016 L, FG 801-014 C STD, FG 801-016 G L, FG 801-012 SHORT, FG 801-035 F STD, FG 801-018 XL, FG 801-014 F STD, FG 801-009 STD, FG 801-014 SHORT, FG 801-010 C STD, FG 801-008 STD, FG 801-010 F STD, FG 801-023 G STD, FG 801-027 G STD, FG 801-010 XL, FG 802-021 STD, FG 801-018 F STD, FG 801-014 G XL, FG 801-009 G STD, FG 801-009 F STD, FG 802-016 G STD, FG 801-010 SHORT, FG 801-033 F STD, FG 801-016 F STD, FG 801-033 STD, FG 802-012 G STD, FG 801-018 G STD, FG 801-027 STD, FG 801-016 XL
Primary DI / UDI-DI
08699401803062, 08699401803031, 08699401802997, 08699401802461, 08699401802928, 08699401802768, 08699401802959, 08699401802683, 08699401802317, 08699401802447, 08699401802874, 08699401802225, 08699401802294, 08699401802836, 08699401802805, 08699401803185, 08699401803116, 08699401802973, 08699401802379, 08699401802263, 08699401802782, 08699401802256, 08699401802591, 08699401802393, 08699401802539, 08699401802362, 08699401803086, 08699401802737, 08699401802409, 08699401802201, 08699401802478, 08699401802232, 08699401802188, 08699401802249, 08699401802829, 08699401802942, 08699401802300, 08699401803239, 08699401802645, 08699401802430, 08699401802195, 08699401802218, 08699401803192, 08699401802287, 08699401803055, 08699401802522, 08699401803048, 08699401803154, 08699401802669, 08699401802966, 08699401802621
Basic UDI-DI
86994018TMTP0177
EMDN Code
L159007 Odontostomatology burs, reusable
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
TR-MF-000026678

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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