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sempermed safe sterile

by HARPS Investment Asia Pte. Ltd. 3 variants

Ref 3000016225, 3000015996, 3000016028, 3000016027, 3000015999, 3000015997, 3000016226Model Sterile, single use, powder free, nitrile, examination glove, ambidextrous, ocean blue, Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, ocean blue, Non sterile, single use, powder free, nitrile, examination glove, ambidextrous, regular blue, extended cuff

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 Number9001570N*F-047OB-S-3TK Basic UDI-DI Date4 May 2026RegisteredStatusActive

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  • Withdrawn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

Trade Name
sempermed safe sterile
sempermed safe
sempermed safe+
Model / Reference
Sterile, single use, powder free, nitrile, examination glove, ambidextrous, ocean blue, 3000016225, Non sterile, 3000015996, regular blue, extended cuff, 3000016028, 3000016027, 3000015999, 3000015997, 3000016226
Primary DI / UDI-DI
09001570551801, 09001570550187, 09001570550552, 09001570550538, 09001570550255, 09001570550217, 09001570551641
Basic UDI-DI
9001570N*F-047OB-S-3TK, 9001570N*F-047OB-N-3SS, 9001570NOF-065RB-N-869
Unit of Use DI
09001570552808, 09001570542250, 09001570553225, 09001570553218, 09001570542281, 09001570542267, 09001570552815
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

  • Sterile YesEUDAMEDNoEUDAMED

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