Skip to content

AKASI Calculator App (mobile version)

by Polichem SA, Lussemburgo, succursale di Mendrisio

Ref 08430308136248Model TD-16

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08430308136248 Basic UDI-DI 08430308136248UDI-DIDate30 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
TD-16, 08430308136248
Primary DI / UDI-DI
08430308136248
Basic UDI-DI
B-08430308136248
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CH-MF-000025294
Authorised representative
Almirall S.A. ES-AR-000019145

Other devices from Polichem SA, Lussemburgo, succursale di Mendrisio

See all devices from Polichem SA, Lussemburgo, succursale di Mendrisio →

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