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Prisafe

by Iscon Surgicals Limited 16 variants

Ref 001G06BS5

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 Number89042248HSY3V Basic UDI-DI 08904224801509UDI-DIDate17 Jun 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  • Withdrawn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

Device Name
Hypodermic Syringes with or Without Needle
Model / Reference
001G06BS5
Primary DI / UDI-DI
08904224801509
Basic UDI-DI
89042248HSY3V
Direct Marketing DI
08904224801509
EMDN Code
A0101010102 Hypodermic syringe needles, w/o safety systems
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

EUDAMED SRN
IN-MF-000009761
Authorised representative
Meddevices Lifesciences B.V. NL-AR-000000594

Other devices from Iscon Surgicals Limited

See all devices from Iscon Surgicals Limited →

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