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Medicīniskā elastīgā tubulārā saite (ortoze)
EUDAMEDClass I (EU MDR)
Ref ELAST 9605-02
Identity
- Trade Name
- Medicīniskā elastīgā tubulārā saite (ortoze) EUDAMED
- Device Name
- Orthopedic products EUDAMED
- Model / Reference
- ELAST 9605-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04750283041592 EUDAMED
- Basic UDI-DI
- 4750283FIXLBX4 EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - 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
Category: Compression/pressure sock/stocking, reusable
Medicīniskā elastīgā tubulārā saite (ortoze) by Tonus Elast Sia — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure sock/stocking, reusable.
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- JOBST Style — BSN MEDICAL, INC. · Class II
- Female compression bodystocking — Eto Garments ApS · Class I
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 e64b4502-8a4d-4732-9cd6-d79b90ef1ea8 61 fields · synced Jun 18, 2026