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Hu-Friedy

by Hu-Friedy Manufacturing Co., LLC United States EUDAMEDGUDID

Ref PPSGKIT6Model Dental Device

Product code EIXEMDN L159003

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0889950Diagnostic1AZ Basic UDI-DIDate20 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889950086800 UDI-DIDate19 Jul 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Hu-Friedy EUDAMED
Hu-Friedy MFG Co., LLC. GUDID
Generic Name
Dental surgical probe, reusable
Model / Reference
Dental Device, PPSGKIT6
Primary DI / UDI-DI
10889950086800
Basic UDI-DI
0889950Diagnostic1AZ
FDA Product Code
EIX
EMDN Code
L159003 Dental and periodontal probes and explorers, reusable
GMDN Term
Dental surgical probe, reusable
Device Class
Class I
Regulation Number
872.4565
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000017104
Authorised representative
Hu-Friedy Europe LLC & Co. KG DE-AR-000005530

Other devices from Hu-Friedy Manufacturing Co., LLC

See all devices from Hu-Friedy Manufacturing Co., LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Premarket Exempt
  • Lot / Batch Number
Other properties (22)
  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED da45b991-efa2-403a-87a3-5d02c5304dae 61 fields · synced 22 Oct 2026
  • FDA UDI 570385f9-b3c9-4a4f-8456-7fb8f51bc5b6 34 fields · synced 30 May 2026