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Myrian® 2.14: XM-NM
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Myrian® 2.14: XM-NMModel Myrian
by Intrasense
Identity
- Trade Name
- Myrian® 2.14: XM-NM EUDAMED
- Device Name
- Myrian EUDAMED
- Model / Reference
- Myrian EUDAMEDMyrian® 2.14: XM-NM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700719701010 EUDAMED
- Basic UDI-DI
- 37007197MyrianGW EUDAMED
- Direct Marketing DI
- 03700719701010 EUDAMED
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Myrian® 2.14: XM-NM by Intrasense — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091001 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 37007197MyrianGW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intrasense
- EUDAMED SRN
- FR-MF-000001551
Sources (2)
- EUDAMED fd44fc7b-ae7b-4f07-8661-ae370cebf7cc 61 fields · synced Oct 6, 2026
- FDA 510(k) K091001 1 fields · synced May 18, 2026