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Aysam

EUDAMED

Class IIb (EU MDR)

Ref A3495034

by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi

Identity

Trade Name
AYSAM EUDAMED
Device Name
DISTAL FEMUR KILITLI CELIK CIVI (DISTAL FEMUR LOCKING SS SCREW NAIL (DFN) 5,0 X 34 MM EUDAMED
Model / Reference
A3495034 EUDAMED

Identifiers

Primary DI / UDI-DI
08684543848132 EUDAMED
Basic UDI-DI
B-08684543848132 EUDAMED
EMDN Code
P09120201 INTRAMEDULLARY NAILS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Arthrodesis intramedullary nail, non-distracting

Aysam by Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Arthrodesis intramedullary nail, non-distracting.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi
EUDAMED SRN
TR-MF-000017437

Sources (1)

  • EUDAMED 451d7ae1-dbf0-46af-ac72-38a0c6bed241 61 fields · synced Jun 19, 2026