Identity
- Trade Name
- MyoStrain EUDAMED
- Device Name
- MyoStrain EUDAMED
- Model / Reference
- 5.2.4 EUDAMEDMyoStrain 6.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B672MYOSTRAIN502040/$$05320204/* EUDAMED+B672MYOSTRAIN060/$$053501X EUDAMED
- Basic UDI-DI
- ++B672MYOSTRAIN2Q EUDAMED
- Direct Marketing DI
- +B672MYOSTRAIN502040/$$05320204/* EUDAMED+B672MYOSTRAIN060/$$053501X EUDAMED
- EMDN Code
- Z11059092 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
MyoStrain by Myocardial 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 | ++B672MYOSTRAIN2Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- Myocardial Solutions, Inc.
- EUDAMED SRN
- US-MF-000018411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d6625136-91ca-408d-93fc-dbbd13d7342d 61 fields · synced Jul 12, 2026
- EUDAMED d99dff8c-15a4-4f7c-ab90-e340977d32c9 61 fields · synced Jul 12, 2026