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Therm-X Split Hose

by Zenith Technical Innovations, LLC.

Ref TX0208

Therm-X Split Hose (TX0208) is an inflatable hot/cold therapy pack/electric pump (EU MDR Class I; FDA Class II) made by Zenith Technical Innovations, LLC., registered in EUDAMED on 26 Mar 2026 (Basic UDI-DI 08500010960208BQ) and listed in FDA GUDID since 2 Aug 2019 (UDI-DI 00850001096478), 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 Number08500010960208BQ Basic UDI-DI 00850001096478UDI-DIDate26 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850001096478 UDI-DI Date2 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08500010960208BQ registered 26 Mar 2026 Active
  • FDA GUDID UDI-DI 00850001096478 listed 2 Aug 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850001096478
  2. Registered EUDAMED 08500010960208BQ

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  • Withdrawn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
Therm-X
Generic name
Inflatable hot/cold therapy pack/electric pump
Device name
Therm-X Split Hose
Model / Ref / Catalog
TX0208, Therm-X Split Umbilical Hose
Primary DI / UDI-DI
00850001096478, 00850001096164
Basic UDI-DI
08500010960208BQ
Direct marketing DI
00850001096478
FDA product code
JOW, ILO, IRP
EMDN code
Z120616 Electromechanical systems for physical therapy
GMDN term
Inflatable hot/cold therapy pack/electric pump
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.5800, 890.5720, 890.5650
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TX0208
GUDID
Therm-X Split Umbilical Hose
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.

Manufacturer details

EUDAMED SRN
US-MF-000047832
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Similar devices in this category

Other devices filed under ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY.

Other devices from Zenith Technical Innovations, LLC.

See all devices from Zenith Technical Innovations, LLC. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date NoGUDIDYesGUDID
Other properties (22, all answered No)