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Medicīniskā elastīgā tubulārā saite (ortoze)
EUDAMEDClass I (EU MDR)
Ref ELAST 9605Ref ELAST 9605-02
Identity
- Trade Name
- Medicīniskā elastīgā tubulārā saite (ortoze) EUDAMED
- Device Name
- Orthopedic products EUDAMED
- Model / Reference
- ELAST 9605 EUDAMEDELAST 9605-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04750283006300 EUDAMED04750283006294 EUDAMED04750283041615 EUDAMED04750283041585 EUDAMED04750283006287 EUDAMED04750283041608 EUDAMED
- Basic UDI-DI
- 4750283ELBOWVK EUDAMED4750283FIXLBX4 EUDAMED4750283MULTI3J 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
Yes
EUDAMEDEUDAMED
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.
- PREGNANCY CORSET-M — HEGELİ ORTOPEDİK ÜRÜNLER SAN.LTD.ŞTİ · Class I
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- JOBST Elvarex — Bsn-Jobst, Inc. · Class II
- Physiologix Ultimate Carpal Tunnel Brace — Fleming Medical · Class I
- Female compression pants — Eto Garments ApS · Class I
- BabyBelt — Anita Dr. Helbig GmbH · Class I
- 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 | 4750283ELBOWVK | Class I | Active |
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Manufacturer
- Manufacturer
- Tonus Elast Sia
- EUDAMED SRN
- LV-MF-000006828
Sources (9)
- EUDAMED 76472b28-e34f-4d67-b360-5507bdc4a0b3 61 fields · synced Aug 1, 2026
- EUDAMED aa46d6fc-815c-4fce-955e-e6036a05300f 61 fields · synced May 17, 2026
- EUDAMED 34abf5c8-7985-49a9-b088-8aaafced5abd 61 fields · synced May 19, 2026
- EUDAMED 7d73fbc9-ae71-4b8b-9e37-bad471086b66 61 fields · synced May 19, 2026
- EUDAMED 6cf10198-700e-4b7a-955b-495223e41d72 61 fields · synced May 19, 2026
- EUDAMED dd4642ee-c08c-454b-9f8b-d05de6b89dac 61 fields · synced May 19, 2026
- EUDAMED a5d70857-dd3f-4ae2-b35c-88423216d515 61 fields · synced Jun 18, 2026
- EUDAMED 0a950f35-aec4-4ae2-bd11-2e754fea5041 61 fields · synced Jul 9, 2026
- EUDAMED 5ce6a63b-c126-4edf-9145-12c24e30986b 61 fields · synced Jul 26, 2026