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Lumbo-Sacral Back Brace
EUDAMEDClass I (EU MDR)
Ref BK-054 SModel BK-008 BK-009 BK-011 BK-012 BK-018 BK-019 BK-026 BK-036 BK-043 BK-044 BK-047 BK-049 BK-056 BK-072 BK-073 BK-074 BK-095 BK-101 BK-103 BK-104 BK-115 BK-055 BK-015 BK-017 etc
Identity
- Device Name
- LUMBO-SACRAL BACK BRACE EUDAMED
- Model / Reference
- BK-008 BK-009 BK-011 BK-012 BK-018 BK-019 BK-026 BK-036 BK-043 BK-044 BK-047 BK-049 BK-056 BK-072 BK-073 BK-074 BK-095 BK-101 BK-103 BK-104 BK-115 BK-055 BK-015 BK-017 etc EUDAMEDBK-054 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978927531218 EUDAMED
- Basic UDI-DI
- 697892753BackBraceLE EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR 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
Lumbo-Sacral Back Brace 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 | 697892753BackBraceLE | 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 61143c75-dc67-4a6b-bc62-4033de8a566e 61 fields · synced Oct 5, 2026