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Therabath TB10

by WR Medical Electronics Co.

Ref 2280Model Therabath, TB10 ADJ, ScentFree, 220V

Therabath TB10 is a physical therapy paraffin wax bath (EU MDD Class IIa; FDA Class II; FDA product code IMC, Bath, Paraffin) made by WR Medical Electronics Co., registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI B-00702173122809) and listed in FDA GUDID since 6 Nov 2019 (UDI-DI 00702173122809), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-00702173122809 Basic UDI-DI 00702173122809UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00702173122809 UDI-DI Date6 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00702173122809 registered 15 Jun 2026 Active
  • FDA GUDID UDI-DI 00702173122809 listed 6 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00702173122809
  2. Registered EUDAMED B-00702173122809

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Therabath
Generic name
Physical therapy paraffin wax bath
Device name
TB10
Model / reference
Therabath EUDAMED
TB10 ADJ EUDAMED
ScentFree EUDAMED
220V EUDAMED
2280 EUDAMED
TB10 GUDID
Primary DI / UDI-DI
00702173122809
Basic UDI-DI
B-00702173122809
FDA product code
IMC
EMDN code
Z120619 Paraffin therapy systems
GMDN term
Physical therapy paraffin wax bath
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.5110
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Therabath, TB10 ADJ, ScentFree, 220V
2280
GUDID
TB10
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 paraffin wax bath

Similar devices in this category

Other devices filed under PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS.

Other devices from WR Medical Electronics Co.

See all devices from WR Medical Electronics Co. →

Properties

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