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sempermed syntegra IR

by HARPS Investment Asia Pte. Ltd. 3 variants

Ref 827056801Model Sterile, single use, powder free, synthetic polyisoprene, surgical glove, anatomically shaped, cream

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9001570PFM-116SC-S-64V Basic UDI-DI 09001570536655UDI-DIDate16 Apr 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  • Withdrawn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

Model / Reference
Sterile, single use, powder free, synthetic polyisoprene, surgical glove, anatomically shaped, cream, 827056801
Primary DI / UDI-DI
09001570536655
Basic UDI-DI
9001570PFM-116SC-S-64V
Unit of Use DI
09001570536440
EMDN Code
T01010203 Polyisopren surgical gloves
Device Class
Class IIa
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

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