Identity
- Trade Name
- Ortho Sandale EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED45590 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042807881 EUDAMED07630042812069 EUDAMED07630042812106 EUDAMED07630042807959 EUDAMED07630042807997 EUDAMED07630042807928 EUDAMED07630042812137 EUDAMED07630042807904 EUDAMED07630042807935 EUDAMED07630042812090 EUDAMED07630042812083 EUDAMED07630042812113 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 Sandale 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 (12)
- EUDAMED bf865965-1efd-4f9d-b573-f454e3441ddb 61 fields · synced Oct 6, 2026
- EUDAMED b529a910-def9-4d5d-95cc-d0e01eb751d1 61 fields · synced May 16, 2026
- EUDAMED 8a703343-446c-4977-8fd5-26635c75019e 61 fields · synced May 16, 2026
- EUDAMED 266dd20a-a9ff-4536-ac60-9a83c3fa6bf9 61 fields · synced May 17, 2026
- EUDAMED 7e987aaa-15d5-4042-bf89-1cb139113dc3 61 fields · synced May 17, 2026
- EUDAMED 168746f7-c89d-4a95-92b9-32f6a2933fb4 61 fields · synced May 19, 2026
- EUDAMED 6417f705-644b-4017-9e9d-cc7958f50765 61 fields · synced May 19, 2026
- EUDAMED 305329ec-8f20-4a80-9099-a612cac36840 61 fields · synced May 19, 2026
- EUDAMED d2beb3d0-deb1-4bca-a889-0384bd8c9765 61 fields · synced May 19, 2026
- EUDAMED 665a2c7f-29af-41ce-814b-2643caa36db7 61 fields · synced May 19, 2026
- EUDAMED cc5a572d-3118-4c4f-9863-e1343bf392d6 61 fields · synced May 19, 2026
- EUDAMED bd62b82d-2f59-49e4-99b1-f41b925c2a69 61 fields · synced May 19, 2026