Identity
- Trade Name
- Fixační dlaha s možností využití extenze EUDAMED
- Device Name
- Fixační dlaha s možností využití extenze EUDAMED
- Model / Reference
- ES-TD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594206470221 EUDAMED
- Basic UDI-DI
- 859420647F10ESTDBS EUDAMED
- Direct Marketing DI
- 08594206470221 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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: Hand/finger splint, reusable
Fixační dlaha s možností využití extenze by EGO Zlín, spol. s r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
- Elastic Bandage — Anji Xinyuan Medical Supplies Co.,Ltd. · Class I
- Plastalume — BROWNMED, INC. · Class I
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- ORTHOSIS FRACTURE WRIST-HAND PLASTICAST — AliMed, LLC · Class I
- MedTextile — Medtex Swiss Ltd · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · 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 | 859420647F10ESTDBS | Class I | Active |
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Manufacturer
- Manufacturer
- EGO Zlín, spol. s r.o.
- EUDAMED SRN
- CZ-MF-000031911
Sources (1)
- EUDAMED 6a4ac3b7-f2f4-4305-b7b6-659fb7eb1bb3 61 fields · synced Jun 18, 2026