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Hermia

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 00859873006226

by Hermes Medical Solutions AB

Identity

Trade Name
Hermia EUDAMEDFDA UDI
Generic Name
Nuclear medicine system workstation FDA UDI
Device Name
Voxel Dosimetry EUDAMED
Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map of the distribution of absorbed radiation dose (a dose map) on the voxel level for patients who have been administered with radioisotopes. Voxel Dosimetry presents the results to the user and the result can be stored for future analysis. The software application can be configured based on user needs. The intended users of Voxel Dosimetry are medical professionals trained in using the system. Voxel Dosimetry is intended for patients of any age and gender undergoing radionuclide therapy. Voxel Dosimetry is only intended for calculating dose for FDA approved radiopharmaceuticals. Voxel Dosimetry should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions. FDA UDI
Model / Reference
00859873006226 EUDAMED
3 FDA UDI
Description
Voxel Dosimetry is a software application for nuclear medicine. Based on user input, Voxel Dosimetry calculates a volumetric map of the distribution of absorbed radiation dose (a dose map) on the voxel level for patients who have been administered with radioisotopes. Voxel Dosimetry presents the results to the user and the result can be stored for future analysis. The software application can be configured based on user needs. The intended users of Voxel Dosimetry are medical professionals trained in using the system. Voxel Dosimetry is intended for patients of any age and gender undergoing radionuclide therapy. Voxel Dosimetry is only intended for calculating dose for FDA approved radiopharmaceuticals. Voxel Dosimetry should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions. FDA UDI

Identifiers

Primary DI / UDI-DI
00859873006226 EUDAMEDFDA UDI
Basic UDI-DI
08598730060026A EUDAMED
510(k) Number
K243919 FDA UDI
FDA Product Code
LLZ FDA UDI
QIH FDA UDI
EMDN Code
Z11029092 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
Nuclear medicine system workstation FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Hermia by Hermes Medical Solutions AB — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hermes Medical Solutions AB
EUDAMED SRN
SE-MF-000023032

Sources (2)

  • EUDAMED 54a70d23-25fb-4176-b75d-579ce8cdfb4c 61 fields · synced Jul 10, 2026
  • FDA UDI efb24928-9253-4618-b4c3-d4a6e9ed881e 34 fields · synced May 30, 2026