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Elbow Brace
EUDAMEDClass I (EU MDR)
Ref EB001Model EB001,EB002,EB003,EB004,EB005,EB101,EB102,EB103,EB104,EB105,EB106,EB107,EB108,EB109,EB010Ref EB004Ref EB003Ref EB109Ref EB105Ref EB107
Identity
- Device Name
- Elbow Brace EUDAMED
- Model / Reference
- EB001,EB002,EB003,EB004,EB005,EB101,EB102,EB103,EB104,EB105,EB106,EB107,EB108,EB109,EB010 EUDAMEDEB001 EUDAMEDEB004 EUDAMEDEB003 EUDAMEDEB109 EUDAMEDEB105 EUDAMEDEB107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976200101295 EUDAMED06976200101325 EUDAMED06976200101318 EUDAMED06976200101424 EUDAMED06976200101387 EUDAMED06976200101400 EUDAMED
- Basic UDI-DI
- 697620010EB00136 EUDAMED
- EMDN Code
- Y090612 ARM AND ELBOW PROTECTIONS 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
Elbow Brace by Xiamen Ortocare Sports Health 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 | 697620010EB00136 | 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 (6)
- EUDAMED 6b87034c-cd4f-4cb3-9996-e886d6027bda 61 fields · synced Oct 6, 2026
- EUDAMED 3e99cb09-d121-41b1-b842-bb1125239cc2 61 fields · synced May 17, 2026
- EUDAMED b06be3d1-73cc-42e2-b586-ac343b690ac4 61 fields · synced May 18, 2026
- EUDAMED 1e9e895c-aa71-4cd8-898a-ed2050dc42f8 61 fields · synced May 18, 2026
- EUDAMED 16d0f7f7-deac-4248-a19f-a61c7354c7ff 61 fields · synced May 18, 2026
- EUDAMED 3e1d82ab-c9b9-4c0c-9aa7-95edda519d97 61 fields · synced May 18, 2026