Skip to content

Susol

by Bailey Instruments Ltd 26 variants

Part of a family of 6 devices: see the family page

Ref SS04-0110Model SS04-0100

Susol (SS04-0110) is a Class I device made by Bailey Instruments Ltd, registered in EUDAMED on 11 Nov 2025 (Basic UDI-DI 506041883SSPOD6327023) and listed in FDA GUDID since 23 Jan 2024 (UDI-DI 05060418832452), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506041883SSPOD6327023 Basic UDI-DI 05060418832452UDI-DIDate11 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060418832452 UDI-DI Date23 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506041883SSPOD6327023 registered 11 Nov 2025 Active
  • FDA GUDID UDI-DI 05060418832452 listed 23 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05060418832452
  2. Registered EUDAMED 506041883SSPOD6327023

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  • Withdrawn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
Susol EUDAMED
Susol® Scalpel Handle Badger Fine GUDID
Generic name
Scalpel handle, single-use
Device name
Susol® Scalpel Handle No.3
Model / reference
SS04-0100, SS04-0110
Primary DI / UDI-DI
05060418832452 EUDAMED
05060418833770 GUDID
Basic UDI-DI
506041883SSPOD6327023
Unit of use DI
05060418833770
FDA product code
GDZ
EMDN code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
GMDN term
Scalpel handle, single-use
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05060418832452
GUDID
05060418833770
Sterilise before useEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists 05060418832452; FDA GUDID lists 05060418833770), so their flags are not compared.

Manufacturer details

EUDAMED SRN
GB-MF-000013119
Authorised representative
MD REPS Ltd XI-AR-000040375

Related devices

Category: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER.

Other devices from Bailey Instruments Ltd

See all devices from Bailey Instruments Ltd →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)