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Back Brace
EUDAMEDClass I (EU MDR)
Ref BK009Model BK001,BK002,BK003,BK004,BK005,BK006,BK007,BK008,BK009,BK010,BK011,BK012,BK013,BK014,BK015,BK021,BK016,BK017,BK018,BK019,BK020,HE201
Identity
- Device Name
- Back Brace EUDAMED
- Model / Reference
- BK001,BK002,BK003,BK004,BK005,BK006,BK007,BK008,BK009,BK010,BK011,BK012,BK013,BK014,BK015,BK021,BK016,BK017,BK018,BK019,BK020,HE201 EUDAMEDBK009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200101523 EUDAMED
- Basic UDI-DI
- 697620010BB00125 EUDAMED
- EMDN Code
- Y090699 DEVICES FOR BODY PROTECTION - OTHER 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
Back Brace by Xiamen Ortocare Sports Health Co., Ltd. — Class I — CE/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 | 697620010BB00125 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Ortocare Sports Health Co., Ltd.
- EUDAMED SRN
- CN-MF-000034229
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 564ef8fd-e58e-40a1-82e5-bcb47f1d1066 61 fields · synced Oct 6, 2026