Identity
- Trade Name
- MRE Phantom Kit EUDAMEDResoundant MRE phantom kit EUDAMED
- Device Name
- MRE Phantom Kit EUDAMEDResoundant MRE phantom kit EUDAMED
- Model / Reference
- REMREP15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850011790069 EUDAMED
- Basic UDI-DI
- B-00850011790069 EUDAMED0850011790REMREP15MD EUDAMED
- EMDN Code
- Z11059080 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDZ11059099 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I 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
MRE Phantom Kit by Resoundant — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00850011790069 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00850011790069 | Class I | Active |
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Manufacturer
- Manufacturer
- Resoundant
- EUDAMED SRN
- US-MF-000037180
- Authorised Representative
- VISAMED GmbH DE-AR-000006285
Sources (2)
- EUDAMED 6b84366e-f092-4c99-af4a-9e7c3a0c0980 61 fields · synced Jul 11, 2026
- EUDAMED 95613f70-b1e2-4aee-b347-5d0b538002a7 61 fields · synced May 18, 2026