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P6000

by Bts SpA

Ref P6KModel 6000

P6000 (BTSP6K) is a Class I device made by Bts SpA, registered in EUDAMED on 13 May 2026 (Basic UDI-DI ++B179P6KR2) and listed in FDA GUDID since 12 Feb 2017 (UDI-DI B179P6K), active as of 6 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 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B179P6KR2 Basic UDI-DI B179P6KUDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB179P6K UDI-DI Date12 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++B179P6KR2 registered 13 May 2026 Active
  • FDA GUDID UDI-DI B179P6K listed 12 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID B179P6K
  2. Registered EUDAMED ++B179P6KR2

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  • Withdrawn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
Gait analysis system
Model / Ref / Catalog
6000, P6K, BTSP6K
Primary DI / UDI-DI
B179P6K
Basic UDI-DI
++B179P6KR2
Direct marketing DI
B179P6K
FDA product code
KHX
EMDN code
Z12062699 Dynamometric systems for movement analysis – other
GMDN term
Gait analysis system
Device class
Class I
Regulation number
890.1575
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gait analysis system

Similar devices

Also classified as Gait analysis system.

Similar devices in this category

Other devices filed under DYNAMOMETRIC SYSTEMS FOR MOVEMENT ANALYSIS.

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Properties

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