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Silicone Ankle Support
EUDAMEDClass I (EU MDR)
Ref 1409-BK-S-1Ref 1409-BK-XL-1Ref 1409-BK-L-1Ref 1409-BG-M-1Ref 1409-BG-XL-1Ref 1409-BG-S-1
Identity
- Trade Name
- Silicone Ankle Support EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 1409-BK-S-1 EUDAMED1409-BK-XL-1 EUDAMED1409-BK-L-1 EUDAMED1409-BG-M-1 EUDAMED1409-BG-XL-1 EUDAMED1409-BG-S-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769140628 EUDAMED04711769140659 EUDAMED04711769140642 EUDAMED04719863690063 EUDAMED04719863690087 EUDAMED04719863690056 EUDAMED
- Basic UDI-DI
- 471986369CL102DF EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Silicone Ankle Support by OPPO Medical Corp. — 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 | 471986369CL102DF | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (6)
- EUDAMED 72e0754c-3603-4532-8f96-21abda2689ac 61 fields · synced Sep 18, 2026
- EUDAMED 818b0a5e-7f29-4e57-997e-5b38fe24bd30 61 fields · synced May 11, 2026
- EUDAMED 8f84c5db-393c-429e-98b2-a02742141fb4 61 fields · synced May 16, 2026
- EUDAMED 74c20b85-53bb-4d4d-8adf-c231a24e6865 61 fields · synced May 18, 2026
- EUDAMED 82d06f24-c405-46be-9019-754214dd6c45 61 fields · synced May 18, 2026
- EUDAMED afe0a6c8-0086-4140-9410-86a11765cffa 61 fields · synced May 19, 2026