Lumbo-Sacral Back Brace
by Dongguan Supercare Medical Products Co., Ltd 116 variants
Ref BK-026 S, BK-055 S, BK-115 S, BK-008 S, BK-073 S, BK-101 S, BR13B, BR7B, BK-018 S, BR20B, BK-097 U, BK-072 S, BR15B, BK-006 U, BR10B, BR6B, BK-031 U, BK-011 S, BK-047 S, BR8B, BR12B, BK-104 S, BK-044 S, BK-001, BR18B, WB-21, BK-096 U, BK-074 XXL, BK-019 XL, BK-015 L, BK-019 XXL, BK-095 XL, BK-035 XXL, BK-019 M, BK-047 XL, BK-039 L, BK-050 L, BK-044 XL, BK-074 M, BK-115 M, BK-047 M, BK-011 XL, BK-039 XL, BK-011 L, BK-015 XL, BK-039 S, BK-018 L, BK-035 M, BK-042 M, BK-051 L, BK-018 XLModel BK-001,BK-004,BK-006,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-052,BK-056,BK-072,BK-073,etc, 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
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697278239BackBraceEB | Date20 Apr 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Lumbo-Sacral Back Brace
- Model / Reference
- BK-001, BK-004, BK-006, 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-052, BK-056, BK-072, BK-073, etc, BK-026 S, BK-055 S, BK-115 S, BK-008 S, BK-073 S, BK-101 S, BR13B, BR7B, BK-018 S, BR20B, BK-097 U, BK-072 S, BR15B, BK-006 U, BR10B, BR6B, BK-031 U, BK-011 S, BK-047 S, BR8B, BR12B, BK-104 S, BK-044 S, BR18B, WB-21, BK-096 U, 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, BK-074 XXL, BK-019 XL, BK-015 L, BK-019 XXL, BK-095 XL, BK-035 XXL, BK-019 M, BK-047 XL, BK-039 L, BK-050 L, BK-044 XL, BK-074 M, BK-115 M, BK-047 M, BK-011 XL, BK-039 XL, BK-011 L, BK-015 XL, BK-039 S, BK-018 L, BK-035 M, BK-042 M, BK-051 L, BK-018 XL
- Primary DI / UDI-DI
- 06972782390096, 06972782390348, 06972782390300, 06972782390034, 06972782390188, 06972782390270, 06972782390461, 06972782390409, 06972782390072, 06972782390539, 06972782390256, 06972782390171, 06972782390485, 06972782390027, 06972782390430, 06972782390393, 06972782390324, 06972782390058, 06972782390133, 06972782390416, 06972782390454, 06972782390294, 06972782390126, 06972782390003, 06972782390515, 06972782390553, 06972782390249, 06978927530532, 06978927530181, 06978927530785, 06978927530198, 06978927530563, 06978927530921, 06978927530167, 06978927530358, 06978927530990, 06978927531119, 06978927530310, 06978927530501, 06978927530709, 06978927530334, 06978927530099, 06978927531003, 06978927530082, 06978927530792, 06978927530976, 06978927530143, 06978927530891, 06978927531065, 06978927531157, 06978927530150
- Basic UDI-DI
- 697278239BackBraceEB, 697892753BackBraceLE
- EMDN Code
- Y060306, Y090699
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000028597
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No