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Bundled Procedure Pack

by Servicio Integral Hospitalario, S.L.U. 69 variants

Ref 789212/GP01

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 Number184350167cpacks01G8 Basic UDI-DI 08435016719134UDI-DIDate24 Nov 2025RegisteredStatusActive

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  • Withdrawn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
CUSTOM OPHTHALMIC PROCEDURE PACK IIa
BUNDLE CUSTOM OPHTHALMIC PROCEDURE PACK IIb
Model / Reference
789212/GP01
Primary DI / UDI-DI
08435016719134
Basic UDI-DI
184350167cpacks01G8, 184350167bpacks01FM
EMDN Code
Q021113 Ophthalmic surgery instrument kits, single-use
Device Class
Class IIa
Class IIb
Medical Purpose
Medical devices intended to be used in an ophthalmic surgical procedure. The products contained in the pack are selected by trained medical professionals who know how to use them correctly, both individually and in combination with other health products.
Bundle of sterile medical devices in their own individual packaging intended to be used in an ophthalmic surgical procedure. The products contained in the pack are selected by trained medical professionals who know how to use them correctly, both individually and in combination with other health products.

Manufacturer details

EUDAMED SRN
ES-PR-000011724

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Properties

  • Sterile