Identity
- Trade Name
- Potītes ortoze EUDAMED
- Device Name
- Orthopedic products EUDAMED
- Model / Reference
- 0310-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04750283085671 EUDAMED
- Basic UDI-DI
- 4750283ANKLEUM EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) 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
Potītes ortoze 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 | 4750283ANKLEUM | Class I | Active |
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Manufacturer
- Manufacturer
- Tonus Elast Sia
- EUDAMED SRN
- LV-MF-000006828
Sources (1)
- EUDAMED 0fbc2530-0639-496b-b389-f3a625ea44d7 61 fields · synced Jun 18, 2026