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sempermed skySense VB (100)

by HARPS Investment Asia Pte. Ltd. 3 variants

Ref 3000016463, 3000016143, 3000016466, 3000016145, 3000016465, 3000016142Model Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, violet blue, Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, regular blue

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9001570NOF-032VB-N-347 Basic UDI-DI Date30 Apr 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  • Withdrawn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

Trade Name
sempermed skySense VB (100)
sempermed skySense (100)
Model / Reference
Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, violet blue, 3000016463, regular blue, 3000016143, 3000016466, 3000016145, 3000016465, 3000016142
Primary DI / UDI-DI
09001570554628, 09001570551450, 09001570554680, 09001570551498, 09001570554666, 09001570551436
Basic UDI-DI
9001570NOF-032VB-N-347, 9001570NOF-032RB-N-32K
Unit of Use DI
09001570553829, 09001570556554, 09001570553867, 09001570556578, 09001570553850, 09001570549020
EMDN Code
T01020204 Nitrile 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