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KKA164534C

by Univet Loupes SpA

Part of a family of 313 devices: see the family page

Ref KKA164534CModel ITA BLACK EDITION

KKA164534C is a Class I device made by Univet Loupes SpA, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 8057147TTL003XP), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8057147TTL003XP Basic UDI-DI 08057147027652UDI-DIDate19 May 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
ITA BLACK EDITION, KKA164534C
Primary DI / UDI-DI
08057147027652
Basic UDI-DI
8057147TTL003XP
EMDN code
L0399 General surgery instruments, reusable - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000027104

Similar devices in this category

Other devices filed under GENERAL SURGERY INSTRUMENTS, REUSABLE.

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Properties

Other properties (14, all answered No)