Identity
- Trade Name
- Open Light EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED40145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042805498 EUDAMED07630042805559 EUDAMED07630042805504 EUDAMED07630042805474 EUDAMED07630042805535 EUDAMED07630042805481 EUDAMED07630042805542 EUDAMED07630042805566 EUDAMED07630042805528 EUDAMED
- Basic UDI-DI
- 76300428Stabilschuhe5M EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Open Light by Künzli SwissSchuh AG — 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 | 76300428Stabilschuhe5M | Class I | Active |
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Manufacturer
- Manufacturer
- Künzli SwissSchuh AG
- EUDAMED SRN
- CH-MF-000044954
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (9)
- EUDAMED a5e98fe9-ab68-4aff-9bf2-a60d03405002 61 fields · synced Oct 5, 2026
- EUDAMED 4c0b57e0-7788-4e48-90d0-161bd7bffa57 61 fields · synced May 16, 2026
- EUDAMED d3613bc4-f235-450c-ac32-d1bc8ee74363 61 fields · synced May 17, 2026
- EUDAMED fe94f926-d18d-4362-922c-b1c5918a510e 61 fields · synced May 17, 2026
- EUDAMED 8160c317-9ef5-43b4-86d5-36a51c4355e2 61 fields · synced May 17, 2026
- EUDAMED 948e7f67-6f94-4ebc-b62e-95a9df1fb7d6 61 fields · synced May 18, 2026
- EUDAMED 04cd4c16-eea6-48c1-9c50-32690fd3ab79 61 fields · synced May 19, 2026
- EUDAMED 811a9579-9215-4cde-bc84-0def46511d8b 61 fields · synced May 19, 2026
- EUDAMED c6ce2f66-ed9c-458f-a63d-7a44e25fc90d 61 fields · synced May 19, 2026