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Raycast® High Precision – Thermoplastic Bolus Material

by Orfit Industries Belgium EUDAMEDGUDID

Ref 8336.SO1/R/53Model 0028

Product code IYEEMDN T030401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number54200287002858 Basic UDI-DIDate23 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05420028751176 UDI-DIDate17 Nov 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Raycast® High Precision – Thermoplastic Bolus Material EUDAMED
Orfit Industries GUDID
Generic Name
Radiological whole-body positioner
Model / Reference
0028, 8336.SO1/R/53
Primary DI / UDI-DI
05420028751176
Basic UDI-DI
54200287002858
Direct Marketing DI
05420028751176
510(k) Number
FDA Product Code
IYE
EMDN Code
T030401 Radiotherapy protection masks
GMDN Term
Radiological whole-body positioner
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.5050
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Safe

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 & raw data

Show properties, registry sources and raw records
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (20)
  • Sterile: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (2)

  • EUDAMED 7959518f-348c-4eac-aeb1-5a64462d1e5f 61 fields · synced 22 Oct 2026
  • FDA UDI 76fd4b30-9505-4797-9478-a89a8b025b41 35 fields · synced 30 May 2026