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Fixture Driver Ratchet

by ARUM DENTISTRY Co., Ltd. EUDAMEDGUDID

Active European Union

Ref FDR27R

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000557SDBW Basic UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800055792842 UDI-DIDate20 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Surgical screwdriver, reusable
Device Name
Screw Driver
Model / Reference
FDR27R
Primary DI / UDI-DI
08800055792842
Basic UDI-DI
88000557SDBW
FDA Product Code
NDP
EMDN Code
Z12110199 Instruments for dental treatment units - other
GMDN Term
Surgical screwdriver, reusable
Device Class
Class I
Regulation Number
872.3980
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Manufacturer details

EUDAMED SRN
KR-MF-000009313
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Other devices from ARUM DENTISTRY Co., Ltd.

See all devices from ARUM DENTISTRY Co., Ltd. →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No