Identity
- Trade Name
- UniSyn Molecular Imaging EUDAMED
- Device Name
- UniSyn Molecular Imaging EUDAMED
- Model / Reference
- 7-4-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B843UNISYNMIE0741P1 EUDAMED
- Basic UDI-DI
- ++B843UNISYNMILF EUDAMED
- Direct Marketing DI
- B843UNISYNMIE0741P1 EUDAMED
- EMDN Code
- Z11029092 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UniSyn Molecular Imaging by Convergent Imaging Solutions Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B843UNISYNMILF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Convergent Imaging Solutions Inc.
- EUDAMED SRN
- CA-MF-000048094
- Authorised Representative
- Easy Medical Device BE-AR-000011902
Sources (1)
- EUDAMED 883f2f25-800b-4575-931b-bad122ff03a6 61 fields · synced Jul 24, 2026