Identity
- Trade Name
- Jakobssons Fotsele EUDAMED
- Device Name
- Jakobssons fotsele EUDAMED
- Model / Reference
- QT 2025 – 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350178580013 EUDAMED
- Basic UDI-DI
- 7350178582025003EN EUDAMED
- Direct Marketing DI
- 07350178580013 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Jakobssons Fotsele by Hjärtshopen AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7350178582025003EN | Class I | Active |
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Manufacturer
- Manufacturer
- Hjärtshopen AB
- EUDAMED SRN
- SE-MF-000048486
Sources (1)
- EUDAMED 3359383d-0b82-46c7-9eb5-dfb19e22aa58 61 fields · synced Jun 19, 2026