Skip to content

DIAVUE Prudential Sicherheits Pen-Nadel

by HTL-Strefa S.A. 2 variants

Ref 8435Model type 820

Active European Union

CE MDD

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/MDD NumberB-05907996095179 Basic UDI-DI 05907996095179UDI-DIDate31 Mar 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Safety pen needle
Model / Reference
type 820, 8435
Primary DI / UDI-DI
05907996095179
Basic UDI-DI
B-05907996095179
EMDN Code
A0101010201 Hypodermic pen needles, with safety systems
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
PL-MF-000002198

Other devices from Htl Strefa S a

See all devices from Htl Strefa S a →

Properties

  • Sterile
  • Administering Medicine

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No