Op-2185-1

by Europack Uluslararasi Sağlik Ve Spor Ürünleri Anoni̇m Şi̇rketi̇ Türkiye EUDAMED

Ref OP-2185-1Model OP-1000 /.../ OP-2505

EMDN Y06120601

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number86839072OP001SW Basic UDI-DI	Date2 May 2025Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: Orthopedics Support Orthoses
Model / Reference: OP-1000 /.../ OP-2505, OP-2185-1

Primary DI / UDI-DI: 08683907244696
Basic UDI-DI: 86839072OP001SW
Direct Marketing DI: 08683907244696
EMDN Code: Y06120601 Passive ankle-foot orthoses

Device Class: Class I
Market of Registration: Türkiye

Manufacturer details

EUDAMED SRN: TR-MF-000038879

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Properties & raw data

Show properties, registry sources and raw records

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No

Sources (1)

EUDAMED 261c0eb9-32df-4190-bef8-e40b011b1bfb 61 fields · synced 24 Oct 2026