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Waterbath MTRH1500EX

by Medtec LLC

Ref MTRH1500EXModel Thermoplastic Devices

Waterbath MTRH1500EX is a Class I device made by Medtec LLC, registered in EUDAMED on 12 May 2026 (Basic UDI-DI 8414391OC0003R13AH) and listed in FDA GUDID since 14 Jun 2018 (UDI-DI 00841439111345), 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 Number8414391OC0003R13AH Basic UDI-DI 00841439111345UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439111345 UDI-DI Date14 Jun 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8414391OC0003R13AH registered 12 May 2026 Active
  • FDA GUDID UDI-DI 00841439111345 listed 14 Jun 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841439111345
  2. Registered EUDAMED 8414391OC0003R13AH

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  • Withdrawn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
Waterbath
Generic name
Thermoplastic-moulding water bath
Model / Ref / Catalog
MTRH1500EX, Thermoplastic Devices
Primary DI / UDI-DI
00841439111345
Basic UDI-DI
8414391OC0003R13AH
FDA product code
KPY
EMDN code
Y0699 External prostheses and orthoses - other
GMDN term
Thermoplastic-moulding water bath
Device class
Class I
Regulation number
892.6500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Thermoplastic-moulding water bath

Similar devices in this category

Other devices filed under EXTERNAL PROSTHESES AND ORTHOSES - OTHER.

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)