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ROM Air Walking Boot
EUDAMEDClass I (EU MDR)
Ref 635202(14XL/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 635202(14L/UNI/Gray&Silver)Ref 635202(14S/UNI/Gray&Silver)Ref 635202(17L/UNI/Black)Ref 635202(S/UNI/Black)Ref 635202(17XS/UNI/Black)Ref 635202(14XL/UNI/Gray&Silver)Ref 635202(17L/UNI/Gray&Silver)Ref 635202(14M/UNI/Black)Ref 635202(17M/UNI/Black)
Identity
- Trade Name
- ROM 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 EUDAMED635202(14XL/UNI/Black) EUDAMED635202(14L/UNI/Gray&Silver) EUDAMED635202(14S/UNI/Gray&Silver) EUDAMED635202(17L/UNI/Black) EUDAMED635202(S/UNI/Black) EUDAMED635202(17XS/UNI/Black) EUDAMED635202(14XL/UNI/Gray&Silver) EUDAMED635202(17L/UNI/Gray&Silver) EUDAMED635202(14M/UNI/Black) EUDAMED635202(17M/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964467854 EUDAMED04719964460046 EUDAMED04719892939973 EUDAMED04719964465546 EUDAMED04719892939959 EUDAMED04719964468516 EUDAMED04719964460077 EUDAMED04719892939980 EUDAMED04719892939942 EUDAMED04719964465539 EUDAMED
- Basic UDI-DI
- 47199644663WN EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
ROM 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 61a3051f-1e09-4eb4-9a28-e009823875f3 61 fields · synced Oct 6, 2026
- EUDAMED 619cf9c7-9420-4b74-b9e9-49e31e2fc8b7 61 fields · synced May 17, 2026
- EUDAMED 7ba2eec8-b663-4b71-8c1c-9479377acb0e 61 fields · synced May 17, 2026
- EUDAMED a11d8c88-87ce-4093-a8a4-0bb4a6eff294 61 fields · synced May 17, 2026
- EUDAMED e6dafd03-09e7-4a5e-b00f-45e9dfea5869 61 fields · synced May 17, 2026
- EUDAMED 17490b26-99fa-4929-8c3a-ba44e01ebeb5 61 fields · synced May 17, 2026
- EUDAMED 5d7c9ad7-8721-4269-8b15-bd9d946976c8 61 fields · synced May 18, 2026
- EUDAMED 9dcb3a50-0900-429e-ac96-7447e6878bdf 61 fields · synced May 19, 2026
- EUDAMED 821fbfeb-ec59-4491-a3cc-0446865dbe17 61 fields · synced May 19, 2026
- EUDAMED 74140793-456c-41a5-b3eb-04d36b6b670e 61 fields · synced May 19, 2026