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Kois Kr-4 Packer 26228

by Pascal Company, Inc.

Part of a family of 23 devices: see the family page

Ref 26228

Kois Kr-4 Packer 26228 is a gingival retraction cord packing tool (EU MDR Class I; FDA Class I; FDA product code EIF, Accessories, Retractor, Dental) made by Pascal Company, Inc., registered in EUDAMED on 7 May 2024 (Basic UDI-DI 03108669001HF) and listed in FDA GUDID since 4 Jun 2024 (UDI-DI 00310866002620), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00310866002620 UDI-DI Date4 Jun 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number03108669001HF Basic UDI-DI 00310866002620UDI-DIDate7 May 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 03108669001HF registered 7 May 2024 Active
  • FDA GUDID UDI-DI 00310866002620 listed 4 Jun 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED 03108669001HF
  2. Listed FDA GUDID 00310866002620

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  • Withdrawn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

Trade name
Kois Packer KR-4 EUDAMED
Kois Kr-4 Packer GUDID
Generic name
Gingival retraction cord packing tool
Device name
Packing Instruments
Model / reference
26228
Primary DI / UDI-DI
00310866002620
Basic UDI-DI
03108669001HF
FDA product code
EIF
EMDN code
Q010204 Retraction wires and gingival retractors
GMDN term
Gingival retraction cord packing tool
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gingival retraction cord packing tool

Similar devices in this category

Other devices filed under RETRACTION WIRES AND GINGIVAL RETRACTORS.

Other devices from Pascal Company, Inc.

See all devices from Pascal Company, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
Other properties (23, all answered No)