Identity
- Trade Name
- Medicīniskais elastīgais apsējs EUDAMED
- Device Name
- Orthopedic products EUDAMED
- Model / Reference
- ELAST 9903-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04750283040472 EUDAMED
- Basic UDI-DI
- 4750283FIXLBX4 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES 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 elastīgais apsējs 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 | 4750283FIXLBX4 | Class I | Active |
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Manufacturer
- Manufacturer
- Tonus Elast Sia
- EUDAMED SRN
- LV-MF-000006828
Sources (1)
- EUDAMED 7de1b081-3c67-4c09-9c64-149723e0003b 61 fields · synced Jun 19, 2026