Identity
- Trade Name
- SynX EUDAMED
- Device Name
- SynX EUDAMED
- Model / Reference
- 1.2 EUDAMED001-014800-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M58800101480010 EUDAMED
- Basic UDI-DI
- ++M5880010148001EY EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - 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
SynX by Stereotaxis, Inc. — Class I — 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 | ++M5880010148001EY | Class I | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
- EUDAMED SRN
- US-MF-000026621
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 4c038390-846b-4ed4-a85a-4f7a39a0ef4f 61 fields · synced Jul 17, 2026