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Euroglove-Qle

by Tg Medical Sdn. Bhd. 6 variants

Ref SA201 – SIZE “8.5” – REF. 05046, SA201 – SIZE “5.5” – REF. 05040, SA201 – SIZE “6.0” – REF. 05041, SA201, SA201 – SIZE “6.5” – REF. 05042

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955583990800Q3 Basic UDI-DI Date26 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  • Withdrawn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
Sterile Latex Surgical Powder Free Glove
Model / Reference
SA201 – SIZE “8.5” – REF. 05046, SA201 – SIZE “5.5” – REF. 05040, SA201 – SIZE “6.0” – REF. 05041, SA201, SA201 – SIZE “6.5” – REF. 05042
Primary DI / UDI-DI
09551004201678, 09551004201616, 09551004201623, 09551004201609, 09551004201630
Basic UDI-DI
955583990800Q3
EMDN Code
T01010102 Non-powdered latex surgical gloves
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
MY-MF-000009606
Authorised representative
Ulma International GmbH DE-AR-000010015

Other devices from Tg Medical Sdn. Bhd.

See all devices from Tg Medical Sdn. Bhd. →

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