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Kit Toma De Muestra Para El Test Ets Hombre

by Ayala Sample Kits, S.L.

Ref ETSH-PACModel SALXH-PRF, ETSH-PAC, SALXH-PAC, VAG-PRF, VAG-PAC, CAL020.01

Active European Union

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8437026387SALUD-STZ Basic UDI-DI 08437026387310UDI-DIDate29 Jul 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Kit De Toma De Muestra Para Tests De Salud Sexual
Model / Reference
SALXH-PRF, ETSH-PAC, SALXH-PAC, VAG-PRF, VAG-PAC, CAL020.01
Primary DI / UDI-DI
08437026387310
Basic UDI-DI
8437026387SALUD-STZ
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000037853

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Properties

  • Professional Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No