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Austofix Plate and Screw System

EUDAMED

Class IIb (EU MDR)

Ref 262510.Model VRP 2.0+ Locking Screw | 2.5 x 10mm

by Australian Orthopaedic Fixations Pty. Ltd.

Identity

Trade Name
Austofix Plate and Screw System EUDAMED
Model / Reference
VRP 2.0+ Locking Screw | 2.5 x 10mm EUDAMED
262510. EUDAMED

Identifiers

Primary DI / UDI-DI
09339430004182 EUDAMED
Basic UDI-DI
B-09339430004182 EUDAMED
EMDN Code
P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

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

Austofix Plate and Screw System by Australian Orthopaedic Fixations Pty. Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
AU-MF-000009151
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED 8351747f-f826-480b-9b3c-585b845033db 61 fields · synced Sep 17, 2026