Identity
- Trade Name
- Synchrony EUDAMED
- Device Name
- Synchrony System EUDAMED
- Model / Reference
- 1 EUDAMED001-010700-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M58800101070010 EUDAMED
- Basic UDI-DI
- ++M5880010107001DD EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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
Synchrony by Stereotaxis, Inc. — Class I — 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 | K253473 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++M5880010107001DD | Class I | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
- EUDAMED SRN
- US-MF-000026621
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 9e0e167c-57d3-43d6-bb89-3f19fa5a8587 61 fields · synced Jul 31, 2026
- FDA 510(k) K253473 1 fields · synced May 18, 2026