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Air Walking Boot
EUDAMEDClass I (EU MDR)
Ref 635102(17S/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 635102(17S/UNI/Gray&Silver)Ref 635102(11S/UNI/Gray&Silver)Ref 635102(11L/UNI/Black)Ref 635102(11XL/UNI/Black)Ref 635102(17M/UNI/Gray&Silver)Ref 635102(11M/UNI/Gray&Silver)Ref 635102(17L/UNI/Gray&Silver)Ref 635102(17L/UNI/Black)Ref 635102(11S/UNI/Black)
Identity
- Trade Name
- 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 EUDAMED635102(17S/UNI/Black) EUDAMED635102(17S/UNI/Gray&Silver) EUDAMED635102(11S/UNI/Gray&Silver) EUDAMED635102(11L/UNI/Black) EUDAMED635102(11XL/UNI/Black) EUDAMED635102(17M/UNI/Gray&Silver) EUDAMED635102(11M/UNI/Gray&Silver) EUDAMED635102(17L/UNI/Gray&Silver) EUDAMED635102(17L/UNI/Black) EUDAMED635102(11S/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719892939751 EUDAMED04719964465416 EUDAMED04719892939621 EUDAMED04719892939683 EUDAMED04719964465447 EUDAMED04719964465423 EUDAMED04719892939607 EUDAMED04719964465430 EUDAMED04719892939713 EUDAMED04719892939706 EUDAMED
- Basic UDI-DI
- 47199644663WN EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES 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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 (10)
- EUDAMED 355a14ed-d0ad-4cd9-a01d-0cded2c64f5c 61 fields · synced Oct 6, 2026
- EUDAMED b04e7476-69d9-49c2-9f08-0a8ac2ac0858 61 fields · synced May 16, 2026
- EUDAMED 92aa4f08-3074-44bf-a9c2-779a416f1b55 61 fields · synced May 16, 2026
- EUDAMED fb36bb41-881b-443c-8d93-55b73eb0ab97 61 fields · synced May 17, 2026
- EUDAMED ab268e03-4710-4e02-8b7b-89ccb3b23f89 61 fields · synced May 17, 2026
- EUDAMED f372b343-97cf-4fa0-a2c0-73c6a6ce5801 61 fields · synced May 17, 2026
- EUDAMED fac8180d-32a5-4586-91ee-4722e669a603 61 fields · synced May 18, 2026
- EUDAMED fcb7a86f-610e-4a6b-828f-dc626c45826e 61 fields · synced May 18, 2026
- EUDAMED c9994ab2-9b94-4531-89b9-827a789b2ae2 61 fields · synced May 19, 2026
- EUDAMED 21b66466-407f-4f64-9953-dffbb7232cea 61 fields · synced May 19, 2026