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Fili Lisci Ø1.8mm L400mm St 2pz

EUDAMED

Class IIb (EU MDR)

Ref 5000340ST2Model Filo

by Mikai s.p.a.

Identity

Trade Name
FILI LISCI Ø1.8MM L400MM ST 2PZ EUDAMED
Device Name
Acciaio EUDAMED
Model / Reference
Filo EUDAMED
5000340ST2 EUDAMED

Identifiers

Primary DI / UDI-DI
08055400670416 EUDAMED
Basic UDI-DI
805573143IMP00000WIRE.SX5 EUDAMED
EMDN Code
P09120301 KIRSCHNER BONE WIRES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Orthopaedic bone pin, non-bioabsorbable

Fili Lisci Ø1.8mm L400mm St 2pz by Mikai s.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Mikai s.p.a.
EUDAMED SRN
IT-MF-000030732

Sources (1)

  • EUDAMED 743415db-0b13-4f15-84f4-2cbc7caced8c 61 fields · synced Jun 18, 2026