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Smart kit Pro SKT-24060

by Bsl Co.

Ref 27Model SKT-24060

Smart kit Pro SKT-24060 is a device classified as Class IIa in the EU and Class II in the US made by Bsl Co., registered in EUDAMED on 11 Mar 2024 (Basic UDI-DI B-08800080201029), listed under FDA premarket submission BK220722 and listed in FDA GUDID since 11 May 2023 (UDI-DI 08800080201029), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK220722

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800080201029 Basic UDI-DI 08800080201029UDI-DIDate11 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08800080201029 UDI-DI Date11 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK220722 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800080201029 registered 11 Mar 2024 Active
  • FDA premarket submission BK220722 Active
  • FDA GUDID UDI-DI 08800080201029 listed 11 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800080201029
  2. Registered EUDAMED B-08800080201029

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Smart kit Pro
Generic name
Autologous adipose tissue reinjection set
Device name
Skt-24060
Model / reference
SKT-24060, 27
Primary DI / UDI-DI
08800080201029
Basic UDI-DI
B-08800080201029
FDA product code
QKL
EMDN code
V901601 Plastic surgery and non-aesthetic purposes generic use instruments and kits, single-use
GMDN term
Autologous adipose tissue reinjection set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.5040
EU registration type
Legacy device (under a directive)
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Cleared under the same submission (BK220722)

and 8 more cleared under BK220722

Similar devices in this category

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

Other devices from Bsl Co.

See all devices from Bsl Co. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)