Identity
- Trade Name
- Hermia EUDAMEDHermia Multimodality Viewer EUDAMEDAffinity FDA UDI
- Generic Name
- Nuclear medicine system workstation FDA UDI
- Device Name
- Hybrid Recon EUDAMEDAffinity EUDAMEDAffinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Affinity is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management. FDA UDI
- Model / Reference
- 00859873006196 EUDAMED00859873006172 EUDAMED4.0 FDA UDI
- Description
- Affinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Affinity is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management. FDA UDI
Identifiers
- Catalog Number
- P60 FDA UDI
- Primary DI / UDI-DI
- 00859873006196 EUDAMED00859873006172 EUDAMEDFDA UDI
- Basic UDI-DI
- 085987300600066 EUDAMED08598730060046E EUDAMED
- FDA Product Code
- KPS 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 IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hermia by Hermes Medical Solutions AB — Class IIa — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085987300600066 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hermes Medical Solutions AB
- EUDAMED SRN
- SE-MF-000023032
Sources (3)
- EUDAMED 54f4c538-9ad6-42fc-8c80-6ead3c524015 61 fields · synced Jul 14, 2026
- EUDAMED 6480e8f5-bcf1-4eb6-8d50-37a9107e99fc 61 fields · synced May 17, 2026
- FDA UDI d139de4a-7529-41af-a343-932f735b7eb7 34 fields · synced May 30, 2026