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10 Patient Consumables Pack

by MediAkris, razvoj in proizvodnja medicinskih naprav d.o.o.

Ref 52177021Model 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 Number383008873CONSUMABLES01HA Basic UDI-DI 03830088730042UDI-DIDate4 Aug 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  • Withdrawn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

Model / Reference
Procedure Pack, 52177021
Primary DI / UDI-DI
03830088730042
Basic UDI-DI
383008873CONSUMABLES01HA
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
Device Class
Class I
Medical Purpose
Sterile procedure pack intended for use with the MediAkris robotic camera controller during minimally invasive surgery. The procedure pack contains ten sterile CE-marked Zoom Modules and twelve sterile CE-marked sleeves. The components are assembled and supplied in accordance with Article 22 of Regulation (EU) 2017/745.

Manufacturer details

EUDAMED SRN
SI-PR-000053051

Other devices from MediAkris, razvoj in proizvodnja medicinskih naprav, d.o.o.

Properties

  • Sterile