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SPA2099 T1 / v1.0

by SPA2099 B.V.

Ref SPA2099-T1Model SPA2099 T1 / v1.0

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8720892SPA2099T1v14Z Basic UDI-DI 08720892000019UDI-DIDate8 Apr 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
T-shirt SPA2099 with integrated electrodes
Model / Reference
SPA2099 T1 / v1.0, SPA2099-T1
Primary DI / UDI-DI
08720892000019
Basic UDI-DI
8720892SPA2099T1v14Z
EMDN Code
Z12050380 Electrocardiographs - hardware accessories
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000047084

Related devices

Category: Electrocardiographic lead set, reusable

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No