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ROM Walker Boot
EUDAMEDClass I (EU MDR)
Ref WK-005-MModel XS,S,M,L,XLRef WK-005-XL
Identity
- Trade Name
- ROM Walker Boot EUDAMED
- Device Name
- Walker Boot EUDAMED
- Model / Reference
- XS,S,M,L,XL EUDAMEDWK-005-M EUDAMEDWK-005-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979025030863 EUDAMED06979025030887 EUDAMED
- Basic UDI-DI
- 697902503WKBTZ EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Orthotic insole, prefabricated, non-antimicrobial
ROM Walker Boot by Xiamen Bosegrow Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 697902503WKBTZ | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Bosegrow Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000048932
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (2)
- EUDAMED ce7483df-0296-4350-a4f4-ca7f9241080a 61 fields · synced Oct 5, 2026
- EUDAMED 4da26389-615b-47d9-8814-9ccfcf431781 61 fields · synced May 19, 2026