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baiobit 1

by Bts SpA

Ref BAIOBIT, BAIOBITCModel G-Walk, BAIOBIT-C

baiobit 1 is a device classified as Class I in the EU and Class II in the US made by Bts SpA, registered in EUDAMED on 14 Jun 2024 (Basic UDI-DI ++B179GS2QR) and listed in FDA GUDID since 14 Dec 2020 (UDI-DI B179BAIO1), 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 Number++B179GS2QR Basic UDI-DI Date14 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberB179BAIO1 UDI-DI Date14 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++B179GS2QR registered 14 Jun 2024 Active
  • FDA GUDID UDI-DI B179BAIO1 listed 14 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B179BAIO1
  2. Registered EUDAMED ++B179GS2QR

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  • Withdrawn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
baiobit
Generic name
Gait analysis system
Device name
GSensor 2
Baiobit-C
Model / reference
G-Walk EUDAMED
BAIOBIT EUDAMED
BAIOBIT-C EUDAMED
BAIOBITC EUDAMED
1 GUDID
Primary DI / UDI-DI
B179BAIO1, B179BAIOBITC0
Basic UDI-DI
++B179GS2QR, ++B179BAIOBITCTH
Direct marketing DI
B179BAIO1
B179BAIOBITC0
FDA product code
HCC
EMDN code
Z12062502, N010299
GMDN term
Gait analysis system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050
Special device type
Software
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
G-Walk
BAIOBIT
BAIOBIT-C
BAIOBITC
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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

Category: Gait analysis system

Similar devices

Also classified as Gait analysis system.

Similar devices in this category

Other devices filed under KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS.

Other devices from Bts SpA

  • Smart Dx Evo Hybrid

    Class II

  • Tmjoint 1.0

    Class II

  • Smart Dx EVO2

    Class II

  • P6000

    Class I

See all devices from Bts SpA →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)