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Helmer PF48-Pro

by HELMER Inc.

Ref PF48-PROModel PF

Helmer PF48-Pro is a Class I device made by HELMER Inc., registered in EUDAMED on 13 May 2026 (Basic UDI-DI 081639402TFR0076W) and listed in FDA GUDID since 8 Feb 2019 (UDI-DI 00816394020988), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081639402TFR0076W Basic UDI-DI 00816394020988UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816394020988 UDI-DI Date8 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081639402TFR0076W registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00816394020988 listed 8 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816394020988
  2. Registered EUDAMED 081639402TFR0076W

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  • Withdrawn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
i.Series EUDAMED
Helmer GUDID
Generic name
Platelet agitator
Model / reference
PF48-Pro, PF
Primary DI / UDI-DI
00816394020988
Basic UDI-DI
081639402TFR0076W
Direct marketing DI
00816394020988
FDA product code
KSQ
EMDN code
Z121799 Blood transfusion instruments - other
GMDN term
Platelet agitator
Device class
Class I
Regulation number
864.9195
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Related devices

Category: Platelet agitator

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 (22, all answered No)