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Profeel Double Gloving Non-Latex

by WRP Asia Pacific Sdn. Bhd. 8 variants

Ref P3385-62

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 Number9557795PI-SG017Q Basic UDI-DI 09557795011137UDI-DIDate19 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Polyisoprene Surgical Gloves, Powder Free, Sterile
Model / Reference
P3385-62
Primary DI / UDI-DI
09557795011137
Basic UDI-DI
9557795PI-SG017Q
EMDN Code
T01010203 Polyisopren surgical gloves
Device Class
Class IIa
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
MY-MF-000004690
Authorised representative
REMESCO HANDELSGESMBH AT-AR-000002669

Other devices from WRP Asia Pacific Sdn. Bhd.

See all devices from WRP Asia Pacific Sdn. Bhd. →

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