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Single Use Professional S221

by Eakin Surgical Limited

Ref S221Model Micro Ear Forceps 5mm

Single Use Professional S221 is a Class I device made by Eakin Surgical Limited, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-05055299103265) and listed in FDA GUDID since 9 Aug 2016 (UDI-DI 05055299103265), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055299103265 Basic UDI-DI 05055299103265UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055299103265 UDI-DI Date9 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055299103265 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 05055299103265 listed 9 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055299103265
  2. Registered EUDAMED B-05055299103265

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  • Withdrawn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
Micro Ear Forceps 5mm EUDAMED
Single Use Professional GUDID
Generic name
ENT foreign body extraction forceps
Model / Ref / Catalog
S221, Micro Ear Forceps 5mm
Primary DI / UDI-DI
05055299103265
Basic UDI-DI
B-05055299103265
FDA product code
GEN
EMDN code
V9012 Non-specialist surgical instruments and kits, single-use
GMDN term
ENT foreign body extraction forceps
Device class
Class I
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: ENT foreign body extraction forceps

Similar devices in this category

Other devices filed under NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE.

Other devices from Eakin Surgical Limited

See all devices from Eakin Surgical Limited →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)