Identity
- Trade Name
- Safe3Omax EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED45145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042806815 EUDAMED07630042806754 EUDAMED07630042806822 EUDAMED07630042806846 EUDAMED07630042806778 EUDAMED07630042806761 EUDAMED07630042806860 EUDAMED07630042806808 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
Safe3Omax 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 (8)
- EUDAMED fcb6a7a9-3b8e-4a81-9112-0bd8690cf7d6 61 fields · synced Jul 30, 2026
- EUDAMED 55ca05e8-da8d-499e-bfeb-c67ed8073ab7 61 fields · synced May 17, 2026
- EUDAMED 0d556ed4-f214-47f1-b453-6ec45fca427b 61 fields · synced May 17, 2026
- EUDAMED e17a111d-a5b2-4425-a419-3f77138c72e9 61 fields · synced May 17, 2026
- EUDAMED fc11edcb-ce97-4a39-be29-8779a52fbd7b 61 fields · synced May 18, 2026
- EUDAMED bd97fe76-8a6c-49a3-b0c2-20fb03fcb87c 61 fields · synced May 19, 2026
- EUDAMED 319f47a8-b131-44b1-8d87-3401e71aa50e 61 fields · synced May 19, 2026
- EUDAMED da06182a-d1a6-4193-862a-21b1e05f8f2d 61 fields · synced May 19, 2026