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Resoundant MR Elastography System
EUDAMEDClass IIa (EU MDR)
Ref RESYS4001-RESYSAB
by Resoundant
Identity
- Trade Name
- Resoundant MR Elastography System EUDAMED
- Device Name
- Resoundant MR Elastography System EUDAMED
- Model / Reference
- RESYS4001-RESYSAB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850011790274 EUDAMED
- Basic UDI-DI
- 0850011790RESYS4001-AB9T EUDAMED
- EMDN Code
- Z11059099 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Resoundant MR Elastography System by Resoundant — 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 | 0850011790RESYS4001-AB9T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Resoundant
- EUDAMED SRN
- US-MF-000037180
- Authorised Representative
- VISAMED GmbH DE-AR-000006285
Sources (1)
- EUDAMED 2b0cdbe8-cc7a-4c32-8436-a77f94cd6b3f 61 fields · synced Jul 23, 2026