Identity
- Trade Name
- Safe3O EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED45140 EUDAMED45145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042806709 EUDAMED07630042806679 EUDAMED07630042806853 EUDAMED07630042806631 EUDAMED07630042806716 EUDAMED07630042806648 EUDAMED07630042806723 EUDAMED07630042806747 EUDAMED07630042806730 EUDAMED07630042806655 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
Safe3O 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 (10)
- EUDAMED 28865293-e5b7-4200-baf7-59652fab6e14 61 fields · synced Oct 6, 2026
- EUDAMED 00f5ebe0-687c-4e51-9d51-31d38043f0a2 61 fields · synced May 16, 2026
- EUDAMED 9b02aee3-0a1f-48dd-8322-69d4b96b3264 61 fields · synced May 17, 2026
- EUDAMED a474efe4-540c-4f48-88f6-bf5dcd6f413f 61 fields · synced May 17, 2026
- EUDAMED 9d46ebf1-a95c-4efe-98ca-37e52c5b0d3c 61 fields · synced May 17, 2026
- EUDAMED 86481471-f133-494e-bbea-91189f236e3c 61 fields · synced May 17, 2026
- EUDAMED ca383b14-dd96-4026-832e-45381edc3ed3 61 fields · synced May 19, 2026
- EUDAMED 0b2772bc-e7d7-47ab-88ce-0b2fc5159463 61 fields · synced May 19, 2026
- EUDAMED 550eb0ab-c59f-4e63-9598-c654545d20fc 61 fields · synced May 19, 2026
- EUDAMED ab019cb2-7075-4f53-ade2-095d8e587f34 61 fields · synced May 19, 2026