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Cast Shoes
EUDAMEDClass I (EU MDR)
Ref FS-11-SModel XS,S,M,L,XL,UniversalRef FS-11Ref FS-14-XL
Identity
- Trade Name
- Cast Shoes EUDAMED
- Device Name
- Ankle Brace EUDAMED
- Model / Reference
- XS,S,M,L,XL,Universal EUDAMEDFS-11-S EUDAMEDFS-11 EUDAMEDFS-14-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979025030979 EUDAMED06979025030757 EUDAMED06979025031006 EUDAMED
- Basic UDI-DI
- 697902503AKBQK EUDAMED
- EMDN Code
- Y090618 LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS) 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
Cast Shoes by Xiamen Bosegrow Medical Equipment 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 | 697902503AKBQK | 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 (3)
- EUDAMED 466b1523-a824-4575-a5e5-86da63ba0300 61 fields · synced Oct 6, 2026
- EUDAMED 2e3acfb7-1fed-4a88-8cb4-6b53d8cc730a 61 fields · synced May 17, 2026
- EUDAMED 788b9d3f-bef5-412c-803f-10d5dbda0851 61 fields · synced May 19, 2026