Identity
- Trade Name
- TruSPECT EUDAMED
- Device Name
- TruSPECT EUDAMED
- Model / Reference
- TruSPECT EUDAMED8010290-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649991184103 EUDAMED
- Basic UDI-DI
- 7649991184TruSPECT6J EUDAMED
- Direct Marketing DI
- 07649991184103 EUDAMED
- EMDN Code
- Z11029082 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TruSPECT by Spectrum Dynamics Medical SA — Class IIb — 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 | 7649991184TruSPECT6J | Class IIb | Active |
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Manufacturer
- Manufacturer
- Spectrum Dynamics Medical SA
- EUDAMED SRN
- CH-MF-000032669
- Authorised Representative
- SPECTRUM DYNAMICS MEDICAL FRANCE SAS FR-AR-000013226
Sources (1)
- EUDAMED 15f3d1d7-eabc-44a0-9dad-9366cb3aef28 61 fields · synced May 23, 2026