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Super Air Walking Boot
EUDAMEDClass I (EU MDR)
Ref 635103(11M/UNI/Black)Model Walking Boot:635101 Air Walking Boot:635102 Super Air Walking Boot:635103 Super Walking Boot:635104 ROM Walking Boot:635201 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 etcRef 635103(11S/UNI/Gray&Silver)Ref 635103(11L/UNI/Gray&Silver)Ref 635103(11XS/UNI/Black)Ref 635103(17L/UNI/Gray&Silver)Ref 635103(11L/UNI/Black)Ref 635103(17L/UNI/Black)Ref 635103(17XS/UNI/Black)Ref 635103(11S/UNI/Black)
Identity
- Trade Name
- Super Air Walking Boot EUDAMED
- Device Name
- Walking Boots (Ankle/foot orthosis) EUDAMED
- Model / Reference
- Walking Boot:635101 Air Walking Boot:635102 Super Air Walking Boot:635103 Super Walking Boot:635104 ROM Walking Boot:635201 ROM Air Walking Boot:635202 ROM Air Walking Boot Pro:635204 etc EUDAMED635103(11M/UNI/Black) EUDAMED635103(11S/UNI/Gray&Silver) EUDAMED635103(11L/UNI/Gray&Silver) EUDAMED635103(11XS/UNI/Black) EUDAMED635103(17L/UNI/Gray&Silver) EUDAMED635103(11L/UNI/Black) EUDAMED635103(17L/UNI/Black) EUDAMED635103(17XS/UNI/Black) EUDAMED635103(11S/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964460978 EUDAMED04719964460947 EUDAMED04719964460923 EUDAMED04719964465454 EUDAMED04719964460848 EUDAMED04719964460961 EUDAMED04719964460886 EUDAMED04719964465461 EUDAMED04719964460985 EUDAMED
- Basic UDI-DI
- 47199644663WN EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Super Air Walking Boot by Orthotech Rehabilitation Co., Ltd. — 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 | 47199644663WN | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (9)
- EUDAMED f6eb84f6-2c71-42de-959b-7371fe154ba2 61 fields · synced Oct 7, 2026
- EUDAMED 81a0d0a3-76ef-47c2-a8c9-6fc05c8427b4 61 fields · synced May 16, 2026
- EUDAMED 4006e4a8-04d9-4c46-a2d3-6225a1bafb09 61 fields · synced May 16, 2026
- EUDAMED 7f2d6518-ae10-4526-8a80-92f5c54d4856 61 fields · synced May 16, 2026
- EUDAMED 3e668a16-6f54-49ee-8e46-83781b2999ca 61 fields · synced May 17, 2026
- EUDAMED 148448e5-1632-46ca-a888-b5f84d5a1d3b 61 fields · synced May 17, 2026
- EUDAMED 661bf9ad-0b40-4f78-9cc6-44c0c57e099f 61 fields · synced May 18, 2026
- EUDAMED 000713c0-9a59-437e-84fc-e54ff977c69d 61 fields · synced May 18, 2026
- EUDAMED 5150968a-c961-4be2-b472-c25bc22dd308 61 fields · synced May 19, 2026