Identity
- Trade Name
- STANDARD KNEE SUPPORT- UNIVERSAL EUDAMED
- Device Name
- ARMALL EUDAMED
- Model / Reference
- ARK5100-STD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680853114172 EUDAMED
- Basic UDI-DI
- 868085311ARMALLL6 EUDAMED
- Direct Marketing DI
- 08680853114172 EUDAMED
- EMDN Code
- Y061209 KNEE 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
Standard Knee Support- Universal by Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇ — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 868085311ARMALLL6 | Class I | Active |
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Manufacturer
- Manufacturer
- Hegeli̇ Ortopedi̇k Ürünler San.ltd.şti̇
- EUDAMED SRN
- TR-MF-000030874
Sources (1)
- EUDAMED f2b147ff-c986-47d4-a2f6-c99c630e59d1 61 fields · synced Oct 5, 2026