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Helmer PC100-Pro

by HELMER Inc.

Ref PC100-PROModel PC

Helmer PC100-Pro is a device classified as Class IIa in the EU and Class II in the US made by HELMER Inc., registered in EUDAMED on 20 May 2026 (Basic UDI-DI B-00816394020940) and listed in FDA GUDID since 8 Feb 2019 (UDI-DI 00816394020940), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816394020940 Basic UDI-DI 00816394020940UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816394020940 UDI-DI Date8 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816394020940 registered 20 May 2026 Active
  • FDA GUDID UDI-DI 00816394020940 listed 8 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816394020940
  2. Registered EUDAMED B-00816394020940

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  • Withdrawn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
i.Series EUDAMED
Helmer GUDID
Generic name
Platelet incubator
Model / reference
PC100-Pro, PC
Primary DI / UDI-DI
00816394020940
Basic UDI-DI
B-00816394020940
FDA product code
KSH
EMDN code
Z121799 Blood transfusion instruments - other
GMDN term
Platelet incubator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
864.9575
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Platelet incubator

Similar devices in this category

Other devices filed under BLOOD TRANSFUSION INSTRUMENTS - OTHER.

Other devices from HELMER Inc.

See all devices from HELMER Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)