Beijing Libeier Bio-Engineering Institute Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000026344 FEI 3035785605
- Devices
- 5,144
- Registrations
- EUDAMED·FDA
- FDA recalls
- 0
What Beijing Libeier Bio-Engineering Institute Co., Ltd. makes
The company manufactures orthopedic locking plate systems designed for internal bone fixation, used in fracture stabilization and surgical reconstruction procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates with a US presence.
AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Non-sterile Bone plates Ref B00401475
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10300311
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10301201
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone plates Ref B00400787
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10301540
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B19000013
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10200579
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone Screws Ref B00000244
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10302779
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10300118
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10300328
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10302029
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10301968
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone Screws Ref B00000205
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10300436
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone plates Ref B00300434
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Bone plates Ref B00400105
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10301821
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone plates Ref B00401224
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10300045
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10302010
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone Screws Ref B00200288
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10302781
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10200563
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10301945
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10300290
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone plates Ref B00400269
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10300014
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10302026
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10300043
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10301823
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone Screws Ref B00000187
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Bone plates Ref B00300563
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10302964
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10200038
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B19000046
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone plates Ref B00400015
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10302832
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone plates Ref B00400096
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Interlocking Intramedullary Nails-Femur Ref B00600027
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Bone plates Ref B00300467
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Bone plates Ref B00300590
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B19000051
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone Screws Ref B00200259
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B10302110
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10200428
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10200091
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Spinal fixation System Ref B10300426
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIINon-sterile Bone plates Ref B00401173
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:IIbNon-sterile Spinal fixation System Ref B19000163
Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED ClassClass:III
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Company details
- EUDAMED SRN
- CN-MF-000026344
- FDA FEI number
- 3035785605
- EUDAMED status
- Active
- EUDAMED registered name
- Beijing Libeier Bio-Engineering Institute Co., Ltd.
- Registered address
- Building 1-B (2nd Floor-A ), No. 5 Wen'an Street, Changping District, Beijing, 102299, China, 102299, Beijing, China
- Website
- www.ak-medical.net/index.html
- [email protected]
- Phone
- 010-80109581
- PRRC contact
- Shan Zhou(public in EUDAMED)