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Pinnacle

by Appasamy Ocular Devices (P) LTD. 15 variants

Ref SP01

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89041255INJECTORDELSYSD8 Basic UDI-DI 08904125593886UDI-DIDate7 Oct 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  • Withdrawn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
Sterile Injector Delivery System
Model / Reference
SP01
Primary DI / UDI-DI
08904125593886
Basic UDI-DI
89041255INJECTORDELSYSD8
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
IN-MF-000019410
Authorised representative
Amstermed B.V. NL-AR-000001971

Other devices from Appasamy Ocular Devices (P) LTD.

See all devices from Appasamy Ocular Devices (P) 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