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Op-2066
EUDAMEDClass I (EU MDR)
Ref OP-2066Model OP-1000 /.../ OP-2505
by Europack Uluslararasi Sağlik Ve Spor Ürünleri Anoni̇m Şi̇rketi̇
Identity
- Trade Name
- OP-2066 EUDAMED
- Device Name
- ORTHOPEDICS SUPPORT ORTHOSES EUDAMED
- Model / Reference
- OP-1000 /.../ OP-2505 EUDAMEDOP-2066 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683907248502 EUDAMED
- Basic UDI-DI
- 86839072OP001SW EUDAMED
- Direct Marketing DI
- 08683907248502 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Category: Ankle/foot orthosis
Op-2066 by Europack Uluslararasi Sağlik Ve Spor Ürünleri Anoni̇m Şi̇rketi̇ — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 86839072OP001SW | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000038879
Sources (1)
- EUDAMED 6b514dcd-b7ef-4d81-89ba-1662bbbd99a0 61 fields · synced Oct 6, 2026