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Lower limb brace
EUDAMEDClass I (EU MDR)
Ref FT-056 SModel BK-055 BK-056 CF-002 CF-003 CF-005 TH-001 TH-003 TH-005 KN-001 KN-003 KN-005 KN-011 KN-012 KN-015 KN-016 KN-017 KN-026 KN-027 KN-028 KN-034 KN-037 KN-039 KN-040 KN-050 KN-052 KN-054 KN-055 KN-062 KN-065 KN-066 KN-069 KN-072 KN-075 etc
Identity
- Device Name
- Lower limb brace EUDAMED
- Model / Reference
- BK-055 BK-056 CF-002 CF-003 CF-005 TH-001 TH-003 TH-005 KN-001 KN-003 KN-005 KN-011 KN-012 KN-015 KN-016 KN-017 KN-026 KN-027 KN-028 KN-034 KN-037 KN-039 KN-040 KN-050 KN-052 KN-054 KN-055 KN-062 KN-065 KN-066 KN-069 KN-072 KN-075 etc EUDAMEDFT-056 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972782391987 EUDAMED
- Basic UDI-DI
- 697278239LowerlimbbraceGD 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
Lower limb brace by Dongguan Supercare Medical Products Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697278239LowerlimbbraceGD | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Supercare Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000028597
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4766d908-5af3-4f10-b59a-6f50a94fe38a 61 fields · synced Jun 18, 2026