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BioAir Superb

by Supervision Optimax Sdn Bhd

Ref P58A1D

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 linked in EUDAMED

A group certificate may exist

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/MDR Number955577490SCLWZ Basic UDI-DI 955577490BAS1DL9UDI-DIDate28 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Soft Contact Lenses
Model / Reference
P58A1D
Primary DI / UDI-DI
955577490BAS1DL9
Basic UDI-DI
955577490SCLWZ
EMDN Code
Q021004010101 Contact lenses - hydrogel, daily single-use
Device Class
Class IIa
Special Device Type
Standard soft contact lenses
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
MY-MF-000034266
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Supervision Optimax Sdn. Bhd.

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Properties

  • Sterile

Other properties (12)

  • 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