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HP PRO Overlay Base Plate - Compatible

by Orfit Industries EUDAMEDGUDID

Active European Union

Ref 25000/87Model Head Positioning System

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5420028700244Y Basic UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05420028701478 UDI-DIDate15 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
HP PRO Overlay Base Plate - Compatible EUDAMED
HP PRO Positioning Device GUDID
Generic Name
Radiological whole-body positioner
Device Name
HP PRO Solution
Model / Reference
Head Positioning System, 25000/87
Primary DI / UDI-DI
05420028701478
Basic UDI-DI
5420028700244Y
510(k) Number
FDA Product Code
IYE
EMDN Code
Z11010180 Linear accelerators - hardware accessories
GMDN Term
Radiological whole-body positioner
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.5050
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
BE-MF-000007872

Other devices from Orfit Industries

See all devices from Orfit Industries →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No