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H200 Wireless System H2W-5000

by Bioness Inc.

Part of a family of 10 devices: see the family page

Ref H2W-5000

H200 Wireless System H2W-5000 is a device classified as Class IIa in the EU and Class II in the US made by Bioness Inc., registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI 081596202FESH00189) and listed in FDA GUDID since 8 Aug 2019 (UDI-DI 00815962020597), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081596202FESH00189 Basic UDI-DI 00815962020597UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00815962020597 UDI-DI Date8 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081596202FESH00189 registered 14 Aug 2026 Active
  • FDA GUDID UDI-DI 00815962020597 listed 8 Aug 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00815962020597
  2. Registered EUDAMED 081596202FESH00189

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  • Withdrawn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
H200 Wireless EUDAMED
H200 Wireless System GUDID
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
H2W-5000
Description
H200 Wireless System Kit, Left (Small)
Primary DI / UDI-DI
00815962020597
Basic UDI-DI
081596202FESH00189
FDA product code
GZI
EMDN code
Z12062780 Functional electrical stimulation systems - hardware accessories
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.5810
EU registration type
Standard device
EU market of registration
Spain
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

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Similar devices in this category

Other devices filed under FUNCTIONAL ELECTRICAL STIMULATION SYSTEMS.

Other devices from Bioness Inc.

See all devices from Bioness Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)