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Lumbo-Sacral back brace
EUDAMEDClass I (EU MDR)
Ref BS025Model BS001 BS002 BS003 BS004 BS005 BS006 BS007 BS008 BS009 BS010 BS011 BS012 BS015 BS016 BS017 BS018 BS019 BS020 BS021 BS022 BS023 BS024 BS025 BS026 BS027Ref BS009Ref BS023Ref BS002Ref BS001 BS002 BS003 BS004 BS005 BS006 etcRef BS017Ref BS024Ref BS006Ref BS001Ref BS018Ref BS028Ref BS021Ref BS004Ref BS016Ref BS029
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 EUDAMEDBS025 EUDAMEDBS009 EUDAMEDBS023 EUDAMEDBS002 EUDAMEDBS001 BS002 BS003 BS004 BS005 BS006 etc EUDAMEDBS017 EUDAMEDBS024 EUDAMEDBS006 EUDAMEDBS001 EUDAMEDBS018 EUDAMEDBS028 EUDAMEDBS021 EUDAMEDBS004 EUDAMEDBS016 EUDAMEDBS029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761565 EUDAMED06975816761428 EUDAMED06975816761541 EUDAMED06975816761350 EUDAMED06975816761404 EUDAMED06975816761480 EUDAMED06975816761558 EUDAMED06975816761398 EUDAMED06975816761442 EUDAMED06975816761343 EUDAMED06975816761497 EUDAMED06975816761596 EUDAMED06975816761527 EUDAMED06975816761374 EUDAMED06975816761473 EUDAMED06975816761435 EUDAMED06975816761602 EUDAMED06975816761459 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 (18)
- EUDAMED 4b084b84-6b91-49a3-9947-2386588a11bf 61 fields · synced Oct 6, 2026
- EUDAMED 23f1f1d4-55a8-4b2b-aaa9-d1e516ed32c8 61 fields · synced May 16, 2026
- EUDAMED bd8c0a10-1e5c-49d1-b501-8b1283632184 61 fields · synced May 16, 2026
- EUDAMED e881517e-7d57-4d6c-bbfb-f2aa7189e291 61 fields · synced May 17, 2026
- EUDAMED 8af4896d-2de0-49c3-af66-7fcbacc5158c 61 fields · synced May 17, 2026
- EUDAMED cf814785-f0d9-409a-b077-139522152148 61 fields · synced May 17, 2026
- EUDAMED 97b280bf-862f-4fa6-aca6-cc55a47f65d3 61 fields · synced May 17, 2026
- EUDAMED dca573ae-2186-4a87-902d-47c8632b56dd 61 fields · synced May 17, 2026
- EUDAMED f97b5a35-90fd-45f5-8b14-ab954408e16b 61 fields · synced May 17, 2026
- EUDAMED 978c6957-36cd-40ba-be14-07e12c9f62d3 61 fields · synced May 18, 2026
- EUDAMED abb06e47-88e3-49bf-9bb6-1d58ce64dd17 61 fields · synced May 18, 2026
- EUDAMED f517f0a9-2904-4a5a-a936-efde00316507 61 fields · synced May 18, 2026
- EUDAMED d8636641-9c60-415e-9c1c-be17f1436103 61 fields · synced May 18, 2026
- EUDAMED cb799b76-4ba7-4630-80a2-49993db9428b 61 fields · synced May 18, 2026
- EUDAMED afb16541-5650-4f90-8047-275b5498dac8 61 fields · synced May 18, 2026
- EUDAMED ab2796f8-5312-4dc7-a16c-68ff7965db0b 61 fields · synced May 18, 2026
- EUDAMED 8a149606-3bf8-4f61-b513-c617d6696fd8 61 fields · synced May 19, 2026
- EUDAMED b4b59752-64df-45b4-a5e8-34ffdc079a19 61 fields · synced May 19, 2026