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Elbow brace
EUDAMEDClass I (EU MDR)
Ref 8005-3Model NS52,NS12,EB40,EB20,EB50,EB60,EB30,EB70,EB80,EB10,EB11,EB12,EB13,EB14,EB15,EB16,EB17,EB18,EB19,EB20,EB21,EB22,EB23,EB24,EB25,NS55,EB26,EB27,EB28,EB29,EB31,EB32,EB33,EB34,EB35, etc
Identity
- Device Name
- Elbow brace EUDAMED
- Model / Reference
- NS52,NS12,EB40,EB20,EB50,EB60,EB30,EB70,EB80,EB10,EB11,EB12,EB13,EB14,EB15,EB16,EB17,EB18,EB19,EB20,EB21,EB22,EB23,EB24,EB25,NS55,EB26,EB27,EB28,EB29,EB31,EB32,EB33,EB34,EB35, etc EUDAMED8005-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934530606583 EUDAMED
- Basic UDI-DI
- 69345306ElbowProtectionZG 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 Yangzhou Jindu Sporting Goods 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 | 69345306ElbowProtectionZG | Class I | Active |
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Manufacturer
- Manufacturer
- Yangzhou Jindu Sporting Goods Co., Ltd.
- EUDAMED SRN
- CN-MF-000041954
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e0ef17eb-feab-40b2-86fa-7bf9648ab230 61 fields · synced Jun 18, 2026