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KALEIDO MANDIBLE Angle Dynamic Compression Plate, 12.3*37.2mm, THK1.25mm, 6Holes
EUDAMEDClass IIb (EU MDR)
Ref 2A1116021201Model U shape bone plate
by Shenzhen World Surgery Medical Device Technology Co., Ltd.
Identity
- Device Name
- KALEIDO MANDIBLE Angle Dynamic Compression Plate,12.3*37.2mm,THK1.25mm,6Holes EUDAMED
- Model / Reference
- U shape bone plate EUDAMED2A1116021201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950292629653 EUDAMED
- Basic UDI-DI
- B-06950292629653 EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
KALEIDO MANDIBLE Angle Dynamic Compression Plate, 12.3*37.2mm, THK1.25mm, 6Holes by Shenzhen World Surgery Medical Device Technology Co., Ltd. — Class IIb…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06950292629653 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000017319
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c2358151-b0de-43ae-95fd-fe87946a3cb2 61 fields · synced Jun 18, 2026