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Perifit Care

by X6 Innovations

Ref Pink

Perifit Care (Pink) is a device classified as Class I in the EU and Class II in the US made by X6 Innovations, registered in EUDAMED on 17 Feb 2026 (Basic UDI-DI 3770014642PER001V5), cleared under FDA 510(k) K231780 on 20 Dec 2023 (1 earlier submission) and listed in FDA GUDID since 3 Aug 2021 (UDI-DI 03770014642110), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231780↗

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3770014642PER001V5 Basic UDI-DI Date17 Feb 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK231780 Date20 Dec 2023IssuedStatusActive
United StatesGUDID listing GUDID Number03770014642110 UDI-DI Date3 Aug 2021ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3770014642PER001V5 registered 17 Feb 2026 Active
  • FDA 510(k) K231780 decided 20 Dec 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03770014642110 listed 3 Aug 2021 Listed

Timeline

4 dated events

  1. Listed FDA GUDID 03770014642110
  2. Cleared FDA 510(k) K221476
  3. Cleared FDA 510(k) K231780
  4. Registered EUDAMED 3770014642PER001V5

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
Perifit Care EUDAMED
Perifit GUDID
Generic name
Pelvic floor muscle exerciser
Model / reference
Pink
Primary DI / UDI-DI
03770014642110 EUDAMED
03760431110194 EUDAMED
03770014642004 GUDID
Basic UDI-DI
3770014642PER001V5
Direct marketing DI
03770014642110
FDA product code
KXQ
EMDN code
U070301 Pelvic floor rehabilitation devices, biofeedback, single-use
GMDN term
Pelvic floor muscle exerciser
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.5960
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
03770014642110
03760431110194
GUDID
03770014642004
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 03770014642110, 03760431110194; FDA GUDID lists 03770014642004), so their flags are not compared. 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.

Manufacturer details

EUDAMED SRN
FR-MF-000029894

Similar devices in this category

Other devices filed under PELVIC FLOOR REHABILITATION DEVICES.

Other devices from X6 Innovations

See all devices from X6 Innovations →

Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)