Hermia Multimodality Viewer
by Hermes Medical Solutions AB Sweden EUDAMEDGUDID
Ref 00859873006172
Product code KPSEMDN Z11029092
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number28620167501 | Date8 Mar 2024 | StatusActive |
| United States | GUDID listing GUDID | Number00859873006172 | Date3 Jul 2023 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Certificates
- 28620167501 Issued
Quality management system EU MDR
- Notified body
- Intertek Medical Notified Body AB 2862
- Issued
- 8 Mar 2024
- Expires
- 3 Oct 2028
Specification
- Generic Name
- Nuclear medicine system workstation
- Model / Reference
- 00859873006172
- Primary DI / UDI-DI
- 00859873006172
- Basic UDI-DI
- 08598730060046E
- FDA Product Code
- KPS
- EMDN Code
- Z11029092 Various instruments for nuclear medicine - medical device software
- GMDN Term
- Nuclear medicine system workstation
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1200
- Special Device Type
- Software
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- SE-MF-000023032
Other devices from Hermes Medical Solutions AB
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- 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
Sources (2)
- EUDAMED 6480e8f5-bcf1-4eb6-8d50-37a9107e99fc
- FDA UDI d139de4a-7529-41af-a343-932f735b7eb7