← Back to catalogue
KangLi
EUDAMEDClass IIb (EU MDR)
Ref T64113512Model Non-sterile Spinal Systems(KSS-I Cervical)
Identity
- Trade Name
- KangLi EUDAMED
- Device Name
- Non-sterile Spinal Systems EUDAMED
- Model / Reference
- Non-sterile Spinal Systems(KSS-I Cervical) EUDAMEDT64113512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937762181804 EUDAMED
- Basic UDI-DI
- 690295900029FU EUDAMED
- Direct Marketing DI
- 06937762181804 EUDAMED
- EMDN Code
- P09070301 CERVICAL 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: Cervical spine immobilization system, single-use
KangLi by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cervical spine immobilization system, single-use.
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- SKYLINE ANTERIOR CERVICAL PLATE SYSTEM — MEDOS INTERNATIONAL SARL · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- SYMPHONY OCT SYSTEM — MEDOS INTERNATIONAL SARL · Class IIb
- MATRIS - Cervical plates and screw — NovaSpine · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
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 | 690295900029FU | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
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 d90769a5-4ee6-4e0e-a07d-e4ce779b6415 61 fields · synced May 23, 2026