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Upper Limbs Supports
EUDAMEDClass I (EU MDR)
Ref EB-011 XLModel SD-001 SD-003 SD-004 SD-013 SD-014 FI-002 BM-003 EB-020 SD-007 EB-007FG-002 FG-006A FG-006B etc
Identity
- Device Name
- UPPER LIMBS SUPPORTS EUDAMED
- Model / Reference
- SD-001 SD-003 SD-004 SD-013 SD-014 FI-002 BM-003 EB-020 SD-007 EB-007FG-002 FG-006A FG-006B etc EUDAMEDEB-011 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978927539207 EUDAMED
- Basic UDI-DI
- 697892753UpperLimbBrace2R EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES 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
Upper Limbs Supports by Dongguan Supercare Medical Products 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 | 697892753UpperLimbBrace2R | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Supercare Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000028597
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6808baa2-2f10-47c0-872d-6d821f8b64dd 61 fields · synced Oct 6, 2026