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Ear Loop

by Ziana Industries 2 variants

Ref C4 107 02, C4 107 03Model C4 107 01

Ear Loop (C4 107 02) is a medical device (EU MDR Class I; EMDN category ent instruments) made by Ziana Industries, registered in EUDAMED on 21 Aug 2025 (Basic UDI-DI 896110270ZI0707EL90080Y7), active as of 22 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number896110270ZI0707EL90080Y7 Basic UDI-DI Date21 Aug 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
BILLEAU LOOP, SMALL 1.5x3MM
Model / reference
C4 107 01, C4 107 02, C4 107 03
Primary DI / UDI-DI
08961102700606, 08961102700613
Basic UDI-DI
896110270ZI0707EL90080Y7
EMDN code
L149099 ENT instruments, reusable - other
Device class
Class I
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
PK-MF-000011900
Authorised representative
International Business Compendious of Sweden SE-AR-000001625

Similar devices in this category

Other devices filed under ENT INSTRUMENTS, REUSABLE - OTHER.

Other devices from Ziana Industries

See all devices from Ziana Industries →

Properties

  • Sterilise before use
  • Reusable
Other properties (12, all answered No)