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Lumbo-Sacral back brace
EUDAMEDClass I (EU MDR)
Ref BS001 BS002 BS003 BS004 BS005 BS006 etcModel BS001 BS002 BS003 BS004 BS005 BS006 BS007 BS008 BS009 BS010 BS011 BS012 BS015 BS016 BS017 BS018 BS019 BS020 BS021 BS022 BS023 BS024 BS025 BS026 BS027
Identity
- Device Name
- Lumbo-Sacral back brace EUDAMED
- Model / Reference
- BS001 BS002 BS003 BS004 BS005 BS006 BS007 BS008 BS009 BS010 BS011 BS012 BS015 BS016 BS017 BS018 BS019 BS020 BS021 BS022 BS023 BS024 BS025 BS026 BS027 EUDAMEDBS001 BS002 BS003 BS004 BS005 BS006 etc EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816760070 EUDAMED
- Basic UDI-DI
- 697581676LSBB0012K EUDAMED
- EMDN Code
- Y061219 CHEST-LUMB-SACRAL-HIP-KNEE-ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 Xiamen Huakang Orthopedic 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 | 697581676LSBB0012K | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 63ada6a1-1c90-4424-bbcc-bdd93eb4741f 61 fields · synced Jun 18, 2026