Identity
- Trade Name
- Ortho Top EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED45595 EUDAMEDY063303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042808543 EUDAMED07630042808536 EUDAMED07630042808598 EUDAMED07630042808482 EUDAMED07630042808499 EUDAMED07630042808581 EUDAMED07630042810508 EUDAMED07630042808550 EUDAMED07630042808529 EUDAMED07630042808451 EUDAMED07630042808444 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 (11)
- EUDAMED fd9b204f-3f93-44a3-895e-15c82be2aba9 61 fields · synced Oct 6, 2026
- EUDAMED 17ef3772-368f-45bb-a528-c3321567d1da 61 fields · synced May 11, 2026
- EUDAMED d63378be-4001-4197-a2b2-cad3e2a03cac 61 fields · synced May 16, 2026
- EUDAMED fec6d81d-b13f-47d9-9837-c5ad42f85dc3 61 fields · synced May 16, 2026
- EUDAMED a49aa838-ead9-4382-952e-60857b472126 61 fields · synced May 16, 2026
- EUDAMED 852454e1-d94b-4baa-8a21-8864344785e2 61 fields · synced May 16, 2026
- EUDAMED 936dfe6a-5156-4502-ace9-40253be3037b 61 fields · synced May 17, 2026
- EUDAMED 762d7a0b-2a6e-4cd2-bd9d-a113a48eaa25 61 fields · synced May 17, 2026
- EUDAMED ca8f863c-8b41-43c3-9227-cffd43339863 61 fields · synced May 17, 2026
- EUDAMED 0b34522e-64b3-4142-8c05-95f3985440e3 61 fields · synced May 17, 2026
- EUDAMED 77106d30-907f-4bbf-ba37-ed89e0b2fbb8 61 fields · synced May 19, 2026