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semperguard vinyl comfort

by HARPS Investment Asia Pte. Ltd. 5 variants

Ref 3000016251Model Non sterile, single use, powder free, vinyl, examination glove, ambidextrous, clear

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, 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/MDR Number9001570VCS-048CL-N-3CN Basic UDI-DI 09001570552242UDI-DIDate5 May 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
Non sterile, single use, powder free, vinyl, examination glove, ambidextrous, clear, 3000016251
Primary DI / UDI-DI
09001570552242
Basic UDI-DI
9001570VCS-048CL-N-3CN
Unit of Use DI
09001570556608
EMDN Code
T01020201 Vinyl examination / treatment gloves
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
SG-MF-000001645
Authorised representative
HARPS Europe GmbH AT-AR-000040870

Other devices from HARPS Investment Asia Pte. Ltd.

See all devices from HARPS Investment Asia Pte. Ltd. →

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