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ClearCalc

by Radformation, Inc. United States EUDAMED510(k)GUDID

Ref 00860001672725, 00850072631004510(k) K193640

Product code MUJEMDN Z119092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08600016727ClearCalcT2 Basic UDI-DIDate21 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00860001672725 UDI-DIDate11 Oct 2021ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK193640 Date9 Apr 2020ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

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

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Generic Name
Radiation therapy software
Model / Reference
00860001672725 EUDAMED
00850072631004 EUDAMED
2.0 GUDID
Version 2.7 GUDID
Primary DI / UDI-DI
00860001672725, 00850072631004
Basic UDI-DI
08600016727ClearCalcT2
510(k) Number
FDA Product Code
MUJ
EMDN Code
Z119092 Various bioimaging and radiotherapy instruments - medical device software
GMDN Term
Radiation therapy software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.5050
Special Device Type
Software
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
00860001672725
00850072631004
GUDID
2.0
Version 2.7
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000009824
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Radformation, Inc.

See all devices from Radformation, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use NoGUDIDYesGUDID
Other properties (23)
  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (5)

  • EUDAMED c5aa7d1b-ccc0-4188-bdd1-9ec1319268f4 85 fields · synced 22 Oct 2026
  • FDA UDI af01931c-eee0-4223-aff0-06ecb1440921 33 fields · synced 30 May 2026
  • EUDAMED 00850072631004|08600016727CLEARCALCT2 61 fields · synced 11 Jul 2026
  • FDA UDI 7bcedf67-7cd9-4f42-947e-d4cc0cfdc1e4 35 fields · synced 22 Oct 2026
  • FDA 510(k) K193640 1 fields · synced 18 May 2026