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SynX

by Stereotaxis, Inc.

Ref 001-014800-1Model 1.2

SynX (001-014800-1) is a Class I device made by Stereotaxis, Inc., registered in EUDAMED on 15 Sep 2025 (Basic UDI-DI ++M5880010148001EY), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++M5880010148001EY Basic UDI-DI M58800101480010UDI-DIDate15 Sep 2025RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
1.2, 001-014800-1
Primary DI / UDI-DI
M58800101480010
Basic UDI-DI
++M5880010148001EY
EMDN code
C020199 Cardiac electrophysiology and mapping devices - other
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000026621
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

Other properties (14, all answered No)