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Hu-Friedy

by Hu-Friedy Manufacturing Co., LLC 1,000+ variants

Part of a family of 84 devices: see the family page

Ref SRMALOModel Dental Device

Hu-Friedy (SRMALO) is a Class I device made by Hu-Friedy Manufacturing Co., LLC, registered in EUDAMED on 14 Mar 2025 (Basic UDI-DI 0889950Hold1RPV) and listed in FDA GUDID since 15 Sep 2020 (UDI-DI 10889950114626), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0889950Hold1RPV Basic UDI-DI 10889950114626UDI-DIDate14 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10889950114626 UDI-DI Date15 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0889950Hold1RPV registered 14 Mar 2025 Active
  • FDA GUDID UDI-DI 10889950114626 listed 15 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10889950114626
  2. Registered EUDAMED 0889950Hold1RPV

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Dental cheek retractor, professional, reusable
Model / Ref / Catalog
Dental Device, SRMALO
Primary DI / UDI-DI
10889950114626
Basic UDI-DI
0889950Hold1RPV
FDA product code
EIG
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Dental cheek retractor, professional, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

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

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Hu-Friedy Manufacturing Co., LLC

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Properties

  • Sterilise before use
  • Reusable
  • Reprocessed single-use device
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)