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ClearLook Lighted MicroLoop, Refill 3420

by Bionix, LLC

Part of a family of 35 devices: see the family page

Ref 3420

ClearLook Lighted MicroLoop, Refill 3420 is an ENT illuminating foreign body extraction set (EU MDR Class I; FDA Class I; FDA product code JYG, Curette, Ear) made by Bionix, LLC, registered in EUDAMED on 23 Apr 2024 (Basic UDI-DI 859911004LightedCuretteKH) and listed in FDA GUDID since 25 Feb 2025 (UDI-DI 00714646001313), active as of 22 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00714646001313 UDI-DI Date25 Feb 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number859911004LightedCuretteKH Basic UDI-DI 00714646001313UDI-DIDate23 Apr 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 859911004LightedCuretteKH registered 23 Apr 2024 Active
  • FDA GUDID UDI-DI 00714646001313 listed 25 Feb 2025 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Registered EUDAMED 859911004LightedCuretteKH
  2. Listed FDA GUDID 00714646001313

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  • Withdrawn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
Lighted Ear Curette EUDAMED
ClearLook Lighted MicroLoop, Refill GUDID
Generic name
ENT illuminating foreign body extraction set
Device name
Lighted Curettes
Model / Ref / Catalog
3420
Primary DI / UDI-DI
00714646001313
Basic UDI-DI
859911004LightedCuretteKH
Unit of use DI
10714646001310
FDA product code
JYG
EMDN code
Q0399 ENT devices - other
GMDN term
ENT illuminating foreign body extraction set
Device class
Class I
Regulation number
874.4420
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Related devices

Category: ENT illuminating foreign body extraction set

Similar devices in this category

Other devices filed under ENT DEVICES - OTHER.

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)