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QuickThaw® DH4

by HELMER Inc.

Ref DH4Model DH

QuickThaw® DH4 is a Class I device made by HELMER Inc., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 081639402TFR0036N) and listed in FDA GUDID since 1 Jul 2016 (UDI-DI 00816394020643), 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 Number081639402TFR0036N Basic UDI-DI 00816394020643UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816394020643 UDI-DI Date1 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081639402TFR0036N registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00816394020643 listed 1 Jul 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816394020643
  2. Registered EUDAMED 081639402TFR0036N

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  • Withdrawn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
Quick Thaw EUDAMED
QuickThaw® GUDID
Generic name
Cryopreserved blood/tissue thawing unit
Model / reference
DH4, DH
Primary DI / UDI-DI
00816394020643
Basic UDI-DI
081639402TFR0036N
Direct marketing DI
00816394020643
FDA product code
LXG
EMDN code
Z121703 Blood and blood components thawers
GMDN term
Cryopreserved blood/tissue thawing unit
Device class
Class I
Regulation number
862.2050
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cryopreserved blood/tissue thawing unit

Similar devices in this category

Other devices filed under BLOOD TRANSFUSION INSTRUMENTS.

Other devices from HELMER Inc.

See all devices from HELMER Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)