Identity
- Trade Name
- Medicīniskais fiksators EUDAMED
- Device Name
- Orthopedic products EUDAMED
- Model / Reference
- TONUS 0411D EUDAMEDTONUS 0411 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04750283065284 EUDAMED04750283082045 EUDAMED04750283014091 EUDAMED04750283065307 EUDAMED04750283082038 EUDAMED04750283014114 EUDAMED04750283014107 EUDAMED
- Basic UDI-DI
- 4750283FIXNCXC EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Latvia 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
Medicīniskais fiksators by Tonus Elast Sia — 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 | 4750283FIXNCXC | Class I | Active |
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Manufacturer
- Manufacturer
- Tonus Elast Sia
- EUDAMED SRN
- LV-MF-000006828
Sources (7)
- EUDAMED 81c5af81-cc0c-4c66-8f59-8a0e7202aaa6 61 fields · synced Jul 26, 2026
- EUDAMED 52518cfc-7fa5-4c75-9f9c-b88a21eb01ac 61 fields · synced May 16, 2026
- EUDAMED d77d5ab2-c8ad-4f57-b25f-478b9973ffc8 61 fields · synced May 16, 2026
- EUDAMED 3774d2cd-7ead-4e3f-bf50-a71ce606a513 61 fields · synced May 17, 2026
- EUDAMED 5277f955-b66d-414b-8e91-92c17351e587 61 fields · synced May 19, 2026
- EUDAMED 6558ff18-a333-4436-acd5-b04aaa23e12b 61 fields · synced May 19, 2026
- EUDAMED d3de629d-627f-4566-9677-acf3d43eada3 61 fields · synced May 19, 2026