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Lower Limbs Braces
EUDAMEDClass I (EU MDR)
Ref KN-042 XXLModel BK-055 BK-056 CF-002 CF-003 TH-001 KN-001 KN-003 KN-005 KN-026 FT-002 FT-006 FT-044 etc
Identity
- Device Name
- Lower Limbs Braces EUDAMED
- Model / Reference
- BK-055 BK-056 CF-002 CF-003 TH-001 KN-001 KN-003 KN-005 KN-026 FT-002 FT-006 FT-044 etc EUDAMEDKN-042 XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978927537463 EUDAMED
- Basic UDI-DI
- 697892753LowerLimbBraceVD EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES 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
Lower Limbs Braces by Dongguan Supercare Medical Products 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 | 697892753LowerLimbBraceVD | 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 27f377f9-47b6-47e8-844e-69b673f75462 61 fields · synced Oct 6, 2026