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Ophthalmological procedure pack

by DINA - HITEX, spol. s r.o.

Ref 201-171-U-SModel Ophthalmologic procedure pack

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 Number8591527006000HPOPT5E Basic UDI-DI 08591527305348UDI-DIDate3 Sep 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  • Withdrawn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
Hitex pack
Model / Reference
Ophthalmologic procedure pack, 201-171-U-S
Primary DI / UDI-DI
08591527305348
Basic UDI-DI
8591527006000HPOPT5E
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class IIb
Medical Purpose
Ophthalmologic procedure pack provides a sterile and comprehensive pack of products necessary for the specific surgical procedure. It protects the patients and medical professionals; it helps to minimize the risk of transmitting microorganisms into the surgical site, thereby reducing the risk of postoperative complications. It is designed to save time and increase efficiency through its layout. It is used in procedures for the modification of anatomical structures within ophthalmic surgery.

Manufacturer details

EUDAMED SRN
CZ-PR-000000561

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Properties

  • Sterile