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H200 Wireless H2W-SW01

by Bioness Inc.

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

Ref H2W-SW01

H200 Wireless H2W-SW01 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 Feb 2018 (UDI-DI 00815962020290), 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 Number081596202FESH00189 Basic UDI-DI 00815962020290UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00815962020290 UDI-DI Date8 Feb 2018ListedStatusListed 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 00815962020290 listed 8 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00815962020290
  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  • Withdrawn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 System EUDAMED
H200 Wireless GUDID
Generic name
Hand orthosis
Model / reference
H2W-SW01
Description
Clinician Programmer Software
Primary DI / UDI-DI
00815962020290
Basic UDI-DI
081596202FESH00189
FDA product code
GZI
EMDN code
Z12062782 Functional electrical stimulation systems - software accessories
GMDN term
Hand orthosis
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
MRI safety
MR Unsafe

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: Hand orthosis

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)