Skip to content

ZipThaw™ 202

by FreMon Scientific

Ref 44700-000Model 202

ZipThaw™ 202 is a device classified as Class I in the EU and Class II in the US made by FreMon Scientific, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 72901152744700NS) and listed in FDA GUDID since 6 Mar 2020 (UDI-DI 07290115270006), 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 Number72901152744700NS Basic UDI-DI 07290115270006UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290115270006 UDI-DI Date6 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 72901152744700NS registered 7 May 2026 Active
  • FDA GUDID UDI-DI 07290115270006 listed 6 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290115270006
  2. Registered EUDAMED 72901152744700NS

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  • Withdrawn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
ZipThaw EUDAMED
ZipThaw™ 202 GUDID
Generic name
Cryopreserved blood/tissue thawing unit
Device name
ZipThaw™
Model / reference
202, 44700-000
Primary DI / UDI-DI
07290115270006
Basic UDI-DI
72901152744700NS
Direct marketing DI
07290115270006
FDA product code
KZL
EMDN code
Z121703 Blood and blood components thawers
GMDN term
Cryopreserved blood/tissue thawing unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
864.9205
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Cryopreserved blood/tissue thawing unit

Other devices from FreMon Scientific

Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (22, all answered No)