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Screw Driver Hand BDHE015

by ARUM DENTISTRY Co., Ltd. EUDAMEDGUDID

Active European Union

Ref BDHE015

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000557SDBW Basic UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800055754956 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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Screw Driver Hand
Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
Screw Driver
Model / Reference
BDHE015
Primary DI / UDI-DI
08800055754956
Basic UDI-DI
88000557SDBW
FDA Product Code
NDP
EMDN Code
Z12110199 Instruments for dental treatment units - other
GMDN Term
Surgical instrument handle, non-torque-limiting
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

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