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Single Use Professional S127

by Eakin Surgical Limited

Part of a family of 9 devices: see the family page

Ref S127

Single Use Professional S127 is a device classified as Class IIa in the EU and Class I in the US made by Eakin Surgical Limited, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 5010058CIIAsT008G00A7S) and listed in FDA GUDID since 19 Aug 2016 (UDI-DI 05055299102213), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5010058CIIAsT008G00A7S Basic UDI-DI 05055299102213UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055299102213 UDI-DI Date19 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5010058CIIAsT008G00A7S registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 05055299102213 listed 19 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055299102213
  2. Registered EUDAMED 5010058CIIAsT008G00A7S

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  • Withdrawn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
Kerrison Rongeur 3mm x 200mm 45˚ EUDAMED
Single Use Professional GUDID
Generic name
Bone-coring punch, single-use
Model / Ref / Catalog
S127
Primary DI / UDI-DI
05055299102213
Basic UDI-DI
5010058CIIAsT008G00A7S
FDA product code
HTX
EMDN code
V9012 Non-specialist surgical instruments and kits, single-use
GMDN term
Bone-coring punch, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution
Size
Angle — 45 degree
Length — 200 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone-coring punch, single-use

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)