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Supermax

by Supermax Glove Manufacturing Sdn Bhd 12 variants

Ref 7.5

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955100345125B7 Basic UDI-DI 09551025330975UDI-DIDate19 Feb 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  • Withdrawn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
Powdered Latex Surgical Gloves
Model / Reference
7.5
Primary DI / UDI-DI
09551025330975
Basic UDI-DI
955100345125B7
EMDN Code
T01010101 Powdered latex surgical gloves
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
MY-MF-000016722
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Supermax Glove Manufacturing Sdn Bhd

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Properties

  • Sterile
  • Contains Latex

Other properties (11)

  • Implantable: No
  • Reusable: 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