Identity
- Trade Name
- Ortho Top EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED45595 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042808437 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
Ortho Top 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 (1)
- EUDAMED b576c1f6-bcfd-47d2-802c-1c22db6c2632 61 fields · synced Jun 18, 2026