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KangLi
EUDAMEDClass IIb (EU MDR)
Ref T5846045Model Non-sterile Spinal Systems(KSS-II, III Lumbar)
Identity
- Trade Name
- KangLi EUDAMED
- Device Name
- Non-sterile Spinal Systems EUDAMED
- Model / Reference
- Non-sterile Spinal Systems(KSS-II, III Lumbar) EUDAMEDT5846045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937762194460 EUDAMED
- Basic UDI-DI
- 690295900030FD EUDAMED
- Direct Marketing DI
- 06937762194460 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Sutures
Yes
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
Category: Spinal bone screw, non-bioabsorbable
KangLi by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Spinal bone screw, non-bioabsorbable.
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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 | 690295900030FD | Class IIb | Active |
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Manufacturer
- Manufacturer
- Suzhou Kangli Orthopaedics Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000016075
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED c3dfe409-5d52-45a4-b515-503b9b35512c 61 fields · synced May 23, 2026