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Spirecut

by Spirecut AG

Ref SB-01-01.01

Spirecut (SB-01-01.01) is a Class I device made by Spirecut AG, registered in EUDAMED on 20 Sep 2024 (Basic UDI-DI 76499889487SBSM) and listed in FDA GUDID since 4 May 2026 (UDI-DI 07649988948725), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07649988948725 UDI-DI Date4 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number76499889487SBSM Basic UDI-DI 07649988948725UDI-DIDate20 Sep 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76499889487SBSM registered 20 Sep 2024 Active
  • FDA GUDID UDI-DI 07649988948725 listed 4 May 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 76499889487SBSM
  2. Listed FDA GUDID 07649988948725

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  • Withdrawn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

Generic name
Instrument tray, reusable
Device name
Sono-Bath
Model / reference
SB-01-01.01
Primary DI / UDI-DI
07649988948725
Basic UDI-DI
76499889487SBSM
FDA product code
LRP
EMDN code
V0480 Clinical use containers (non-IVD) - accessories
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CH-MF-000030994
Authorised representative
Medicina Legatis SRL BE-AR-000026599

Related devices

Category: Surgical instrument/implant rack

Similar devices in this category

Other devices filed under CLINICAL USE CONTAINERS (NON-IVD).

Other devices from Spirecut AG

  • Spirecut

    Class IIa

  • Spirecut

    Class IIa

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (23, all answered No)