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ClearLook CeraSpoon 3350

by Bionix, LLC

Ref 3350

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00714646001597 UDI-DI Date22 Nov 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number859911004LightedCuretteKH Basic UDI-DI 00714646001597UDI-DIDate23 Apr 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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 CeraSpoon GUDID
Generic Name
ENT illuminating foreign body extraction set
Device Name
Lighted Curettes
Model / Ref / Catalog
3350
Primary DI / UDI-DI
00714646001597
Basic UDI-DI
859911004LightedCuretteKH
Unit of Use DI
10714646001594
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 market of registration
Belgium
GUDID distribution status
In Commercial Distribution

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 (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No