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Shoulder Arm Sling
EUDAMEDClass I (EU MDR)
Ref SL013Model SL001 SL002 SL003 SL004 SL005 SL006 SL007 SL008 SL009 SL010 SL011 SL012 SL013 SL014 KB005
Identity
- Device Name
- Shoulder Arm Sling EUDAMED
- Model / Reference
- SL001 SL002 SL003 SL004 SL005 SL006 SL007 SL008 SL009 SL010 SL011 SL012 SL013 SL014 KB005 EUDAMEDSL013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761312 EUDAMED
- Basic UDI-DI
- 697581676SAS001SM EUDAMED
- EMDN Code
- U070101 SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE 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
Shoulder Arm Sling 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 | 697581676SAS001SM | 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 (1)
- EUDAMED 6b370613-2f56-4f8d-a151-c49ea5b25088 61 fields · synced Jun 19, 2026