Identity
- Trade Name
- Ortho Air EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED45594 EUDAMED45596 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042808321 EUDAMED07630042808413 EUDAMED07630042808369 EUDAMED07630042808420 EUDAMED07630042808260 EUDAMED07630042808253 EUDAMED07630042808635 EUDAMED07630042808376 EUDAMED07630042808284 EUDAMED07630042808307 EUDAMED07630042808383 EUDAMED07630042808406 EUDAMED07630042808239 EUDAMED07630042808352 EUDAMED07630042808345 EUDAMED07630042808390 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 Air 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 (16)
- EUDAMED 4a2bd501-e4f1-4211-b734-7d65415de8cc 61 fields · synced Jul 31, 2026
- EUDAMED cd3b9817-369a-40a5-b783-b0f65eb9f2a0 61 fields · synced May 16, 2026
- EUDAMED cdf79c36-c57b-4bf6-bce0-86b63f9b340d 61 fields · synced May 16, 2026
- EUDAMED 83472563-60a5-40f5-8090-99087dbcc6ab 61 fields · synced May 17, 2026
- EUDAMED ebf579db-1c1d-4aa3-8e20-f475e761cb77 61 fields · synced May 17, 2026
- EUDAMED 8f33e2bf-d856-424a-aeda-afe2092c6f1f 61 fields · synced May 17, 2026
- EUDAMED 98c48ba2-e001-42b3-9b7b-65173404dda7 61 fields · synced May 18, 2026
- EUDAMED ecf91f46-438a-4f1e-970a-6b73c96721af 61 fields · synced May 18, 2026
- EUDAMED bde2e452-ea30-4223-8480-09416d79671b 61 fields · synced May 18, 2026
- EUDAMED e9eeda43-69a0-4846-9b6c-928b5d0f52b2 61 fields · synced May 19, 2026
- EUDAMED 3c2b504c-67c8-4535-8336-c7e99f5277c2 61 fields · synced May 19, 2026
- EUDAMED 07dc3f92-b3d3-48ca-930c-9ba5e65aecb7 61 fields · synced May 19, 2026
- EUDAMED 765b582e-bfb1-4b26-bc03-8a70569053ee 61 fields · synced May 19, 2026
- EUDAMED 8bd5cf18-bf09-4237-8e0c-c7012d50d3fe 61 fields · synced May 19, 2026
- EUDAMED 33086bac-dd25-455d-aeb7-3470b4b6f421 61 fields · synced May 19, 2026
- EUDAMED a2567635-8bd0-4464-997a-7a5bd021fd7c 61 fields · synced May 19, 2026