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Medicīniskā elastīgā saite (ortoze)
EUDAMEDClass I (EU MDR)
Ref ELAST 9610Ref ELAST 0005
Identity
- Trade Name
- Medicīniskā elastīgā saite (ortoze) EUDAMED
- Device Name
- Orthopedic products EUDAMED
- Model / Reference
- ELAST 9610 EUDAMEDELAST 0005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04750283006317 EUDAMED04750283020207 EUDAMED04750283020238 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
Yes
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
Medicīniskā elastīgā saite (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 (3)
- EUDAMED 76d31017-d3c2-414d-99c4-db28b06461e5 61 fields · synced Jul 26, 2026
- EUDAMED a9cca39d-88ac-498d-b020-3dbe43db2cde 61 fields · synced May 16, 2026
- EUDAMED be65008e-30d3-439b-b27c-f6366fe57958 61 fields · synced May 17, 2026