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Dts-3000 Dtssbset

by Daesung Maref Co., Ltd.

Part of a family of 42 devices: see the family page

Ref DTSSBSET

Dts-3000 Dtssbset is a Class I device made by Daesung Maref Co., Ltd., registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI 880931567DTSCUFF4D) and listed in FDA GUDID since 16 Jun 2021 (UDI-DI 08809315676168), 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
European UnionCE/MDR EUDAMED Number880931567DTSCUFF4D Basic UDI-DI 08809315676168UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809315676168 UDI-DI Date16 Jun 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880931567DTSCUFF4D registered 14 Jul 2026 Active
  • FDA GUDID UDI-DI 08809315676168 listed 16 Jun 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809315676168
  2. Registered EUDAMED 880931567DTSCUFF4D

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  • Withdrawn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
Dts-3000
Generic name
Surgical pneumatic tourniquet system
Device name
Dts Cuff
Model / reference
DTSSBSET
Primary DI / UDI-DI
08809315676168
Basic UDI-DI
880931567DTSCUFF4D
FDA product code
KCY
EMDN code
Z12139080 Various orthopaedic and traumatology instruments - hardware accessories
GMDN term
Surgical pneumatic tourniquet system
Device class
Class I
Regulation number
878.5910
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical pneumatic tourniquet system

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Daesung Maref Co., Ltd.

See all devices from Daesung Maref Co., Ltd. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)