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KangLi
EUDAMEDClass IIb (EU MDR)
Ref T8211300Model Non-sterile Intramedullary Nailing Systems(Titanium alloy)
Identity
- Trade Name
- KangLi EUDAMED
- Device Name
- Non-sterile Intramedullary Nailing Systems EUDAMED
- Model / Reference
- Non-sterile Intramedullary Nailing Systems(Titanium alloy) EUDAMEDT8211300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937762168041 EUDAMED
- Basic UDI-DI
- 690295900025FL EUDAMED
- Direct Marketing DI
- 06937762168041 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS 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: Arthrodesis intramedullary nail, non-distracting
KangLi by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class IIb — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · 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 | 690295900025FL | 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 fb1ba6cc-1cfd-4ca4-99dc-24d91302d82b 61 fields · synced Oct 7, 2026