Identity
- Trade Name
- Ortho Donna EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED45570 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042807164 EUDAMED07630042807270 EUDAMED07630042807256 EUDAMED07630042807201 EUDAMED07630042807232 EUDAMED07630042807171 EUDAMED07630042807300 EUDAMED07630042807225 EUDAMED07630042807218 EUDAMED07630042807195 EUDAMED07630042807263 EUDAMED07630042807188 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 Donna 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 d381e042-f84d-4971-a5ce-b851d90e6eef 61 fields · synced Oct 6, 2026
- EUDAMED 178d39b2-019f-46a8-b677-3c27460d6dcb 61 fields · synced May 11, 2026
- EUDAMED af54973e-5d44-4628-b73e-ce3e5003155f 61 fields · synced May 17, 2026
- EUDAMED 44d9ee3f-d79b-4139-b907-5dd03fdacc4e 61 fields · synced May 17, 2026
- EUDAMED c8e348ac-218a-49d9-9326-162b4e55b699 61 fields · synced May 18, 2026
- EUDAMED 6af143b8-f612-4f0c-ad19-e2ac08c08985 61 fields · synced May 18, 2026
- EUDAMED e2aa627f-8155-4ac2-9238-f5c166961454 61 fields · synced May 18, 2026
- EUDAMED 7fb7bb87-aac1-4265-816e-276232178e04 61 fields · synced May 19, 2026
- EUDAMED a65e3946-1261-4f08-a803-feb16550de35 61 fields · synced May 19, 2026
- EUDAMED c783fae8-482b-4d9d-a8d1-5e90fa4a31e1 61 fields · synced May 19, 2026
- EUDAMED 3985ef64-4b1e-41ba-8b46-8d891f841d1b 61 fields · synced May 19, 2026
- EUDAMED 51a37561-445e-45eb-9c2b-e03d57cc5efc 61 fields · synced May 19, 2026