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KangLi
EUDAMEDClass IIb (EU MDR)
Ref T5875030Model 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) EUDAMEDT5875030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937762198932 EUDAMED
- Basic UDI-DI
- 690295900030FD EUDAMED
- Direct Marketing DI
- 06937762198932 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
KangLi by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class IIb — 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 | 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 ad7521ef-c973-4834-a45d-e1ab22205e61 61 fields · synced May 23, 2026