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HyFlex EDM 60019363

by Coltène/Whaledent GmbH + Co. KG

Ref 60019363Model HyFlex file

HyFlex EDM 60019363 is a device classified as Class IIa in the EU and Class I in the US made by Coltène/Whaledent GmbH + Co. KG, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI B-E165600193630) and listed in FDA GUDID since 22 Sep 2023 (UDI-DI E165600193630), active as of 12 Nov 2026.

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

CE MDD

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-E165600193630 Basic UDI-DI E165600193630UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE165600193630 UDI-DI Date22 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-E165600193630 registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI E165600193630 listed 22 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E165600193630
  2. Registered EUDAMED B-E165600193630

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
HyFlex EDM Shaping Set Simple 25/.12, 10/.05, 25/.~, 25mm EUDAMED
HyFlex EDM GUDID
Generic name
Rotary/reciprocating endodontic file/rasp, reusable
Device name
HyFlex EDM file
Model / Ref / Catalog
60019363, HyFlex file
Primary DI / UDI-DI
E165600193630
Basic UDI-DI
B-E165600193630
FDA product code
EKS
EMDN code
L159004 Endodontic rasps and files, reusable
GMDN term
Rotary/reciprocating endodontic file/rasp, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI E165600193630: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Rotary/reciprocating endodontic file/rasp, reusable

Similar devices in this category

Other devices filed under ENDODONTIC RASPS AND FILES, REUSABLE.

Other devices from Coltène/Whaledent GmbH + Co. KG

See all devices from Coltène/Whaledent GmbH + Co. KG →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)