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Body Shape

by Active Optical Systems Ltd

Ref 311

Body Shape (311) is a multi-modality skin surface treatment system (EU MDR Class I; FDA Class I; FDA product code BXB, Exerciser, Powered) made by Active Optical Systems Ltd, registered in EUDAMED on 28 Jun 2022 (Basic UDI-DI 7290016727RFFU) and listed in FDA GUDID since 9 Jan 2017 (UDI-DI 07290016727036), 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 Number7290016727RFFU Basic UDI-DI 07290016727036UDI-DIDate28 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016727036 UDI-DI Date9 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7290016727RFFU registered 28 Jun 2022 Active
  • FDA GUDID UDI-DI 07290016727036 listed 9 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290016727036
  2. Registered EUDAMED 7290016727RFFU

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  • Withdrawn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
Multi-modality skin surface treatment system
Model / reference
311 EUDAMED
RF-311N GUDID
Primary DI / UDI-DI
07290016727036
Basic UDI-DI
7290016727RFFU
FDA product code
BXB
EMDN code
G030699 Devices for the non-surgical treatment of obesity - other
GMDN term
Multi-modality skin surface treatment system
Device class
Class I
Regulation number
890.5380
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
311
GUDID
RF-311N

Manufacturer details

EUDAMED SRN
IL-MF-000024754
Authorised representative
QS MEDICAL DEVICE REGISTRATION LTD CY-AR-000024665

Similar devices in this category

Other devices filed under DEVICES FOR THE NON-SURGICAL THERAPY OF OBESITY.

Other devices from Active Optical Systems Ltd

  • Spirit 916

    Class II

  • Crystal 512

    Class II

  • Top Epil Classic 1

    Class I

  • Sheerwave 360

    Class II

See all devices from Active Optical Systems Ltd →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)