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Ortho Standard Max
EUDAMEDClass I (EU MDR)
Ref 45599Model StabilschuheRef 45597
Identity
- Trade Name
- Ortho Standard Max EUDAMEDOrtho Standard EUDAMED
- Device Name
- Ortho Rehab 3 EUDAMED
- Model / Reference
- Stabilschuhe EUDAMED45599 EUDAMED45597 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630042812007 EUDAMED07630042811888 EUDAMED07630042811871 EUDAMED07630042811918 EUDAMED07630042808888 EUDAMED07630042811963 EUDAMED07630042811826 EUDAMED07630042811864 EUDAMED07630042809137 EUDAMED07630042808925 EUDAMED07630042811932 EUDAMED07630042808932 EUDAMED07630042811987 EUDAMED07630042811925 EUDAMED07630042809083 EUDAMED07630042809014 EUDAMED07630042808970 EUDAMED07630042811857 EUDAMED07630042811956 EUDAMED07630042811949 EUDAMED07630042809052 EUDAMED07630042808949 EUDAMED07630042809069 EUDAMED07630042812038 EUDAMED07630042809113 EUDAMED07630042808918 EUDAMED07630042811970 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 Standard Max 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 (27)
- EUDAMED 7f424229-2d23-480a-991c-4cf43d00a9c8 61 fields · synced Aug 1, 2026
- EUDAMED 3609ec80-1ac4-4bcd-83e9-cd7dc5818e6a 61 fields · synced May 16, 2026
- EUDAMED 5078374d-30d0-4a9e-b6d3-7a3f34c5232e 61 fields · synced May 16, 2026
- EUDAMED e89385eb-4b6a-428b-9424-95e18a0d2760 61 fields · synced May 16, 2026
- EUDAMED b756b238-1e04-461b-ab51-aaeb481ebd91 61 fields · synced May 16, 2026
- EUDAMED 2d93dd0f-e167-4497-ab1e-5e426f2c9370 61 fields · synced May 16, 2026
- EUDAMED bb477c96-9e54-49f9-8cee-addbf9224b80 61 fields · synced May 16, 2026
- EUDAMED 7aadccb6-413d-47e6-a03f-bbc93cd593ce 61 fields · synced May 16, 2026
- EUDAMED eab531bc-0eab-43ea-a7a9-9fdf2302057d 61 fields · synced May 16, 2026
- EUDAMED f04a37b1-1469-4ef0-9b06-439a4e330e7b 61 fields · synced May 17, 2026
- EUDAMED d4874b74-b4b0-4a8d-8323-d8a87b57dfcd 61 fields · synced May 17, 2026
- EUDAMED a229b2e1-30c9-49ab-8bf4-b00c8460b0ef 61 fields · synced May 17, 2026
- EUDAMED 82780a86-cab6-47fe-822c-87cf684ee885 61 fields · synced May 17, 2026
- EUDAMED ce578d78-f0d8-4014-a756-001191d50dbc 61 fields · synced May 17, 2026
- EUDAMED 692b3691-1cb9-4a0c-a38f-1c6bc8eaab6b 61 fields · synced May 17, 2026
- EUDAMED 8e6622b0-c0d5-43bf-b945-90a8b0a20f86 61 fields · synced May 17, 2026
- EUDAMED 467ca1ac-7b04-4ba9-ab3c-6ecb44a18dcb 61 fields · synced May 17, 2026
- EUDAMED c8bc1720-87ad-4bf6-929d-e1edcb18be80 61 fields · synced May 17, 2026
- EUDAMED b897cf0f-45eb-4a06-890e-9880a0e5f5d9 61 fields · synced May 17, 2026
- EUDAMED e84f3d32-6c63-468a-b64d-670764db5579 61 fields · synced May 18, 2026
- EUDAMED 2a7dd2bf-1d87-4783-9178-e44705b93382 61 fields · synced May 18, 2026
- EUDAMED 750f3fbe-7a74-4dab-9071-39571907ef22 61 fields · synced May 19, 2026
- EUDAMED 726936cd-0ad3-48da-bf97-e32a0314e8b5 61 fields · synced May 19, 2026
- EUDAMED c82921ee-b5fc-4609-acda-fa140e136728 61 fields · synced May 19, 2026
- EUDAMED 0c69b496-44de-4465-a3ec-a7cc5a7329ed 61 fields · synced May 19, 2026
- EUDAMED 12cad76e-fdf2-4794-b267-ac9e37694e6b 61 fields · synced May 19, 2026
- EUDAMED cd2e88a0-475d-46d9-9da6-ee1b1bd10fc5 61 fields · synced May 19, 2026