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Clavicle Splint
EUDAMEDClass I (EU MDR)
Ref CB003Model CB001 CB002 CB003Ref CB002Ref CB001
Identity
- Device Name
- Clavicle Splint EUDAMED
- Model / Reference
- CB001 CB002 CB003 EUDAMEDCB003 EUDAMEDCB002 EUDAMEDCB001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761183 EUDAMED06975816761176 EUDAMED06975816761169 EUDAMED
- Basic UDI-DI
- 697581676CS001LK EUDAMED
- EMDN Code
- L03130403 SPLINTER FORCEPS, REUSABLE 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
Clavicle Splint 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 | 697581676CS001LK | 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 (3)
- EUDAMED 8e4f982d-4178-4ae7-b791-51afef4341ea 61 fields · synced Oct 6, 2026
- EUDAMED 1b19f607-8ec0-4243-b6c9-b012ec02962b 61 fields · synced May 17, 2026
- EUDAMED d1e51d7d-65bf-4220-bb7d-4d3883a702d2 61 fields · synced May 18, 2026