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Dental Instrument

by Cowellmedi Co., Ltd. 465 variants

Ref KSSE01

Dental Instrument (KSSE01) is a Class I device made by Cowellmedi Co., Ltd, registered in EUDAMED on 23 May 2024 (Basic UDI-DI B-08800016105452) and listed in FDA GUDID since 8 Aug 2024 (UDI-DI 08800016105452), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800016105452 UDI-DI Date8 Aug 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08800016105452 Basic UDI-DI 08800016105452UDI-DIDate23 May 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800016105452 registered 23 May 2024 Active
  • FDA GUDID UDI-DI 08800016105452 listed 8 Aug 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED B-08800016105452
  2. Listed FDA GUDID 08800016105452

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  • Withdrawn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
Dental Instrument EUDAMEDGUDID
Sinus Elevator EUDAMED
Generic name
Dental elevator, sinus lift
Device name
COWELL® Reusable Surgical Instrument
Model / reference
KSSE01
Primary DI / UDI-DI
08800016105452
Basic UDI-DI
B-08800016105452, 880947172M01REA23A08UA
FDA product code
DZN
EMDN code
L80 Surgical instruments, reusable - various accessories
GMDN term
Dental elevator, sinus lift
Device class
Class I
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
KR-MF-000009689
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES.

Other devices from Cowellmedi Co., Ltd

See all devices from Cowellmedi Co., Ltd →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)