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KALEIDO MANDIBLE Crescent Dynamic Compression Plate, 11.7*44.3mm, THK1.25mm, 6H…
EUDAMEDClass IIb (EU MDR)
Ref 2A1116031201Model U shape bone plate
by Shenzhen World Surgery Medical Device Technology Co., Ltd.
Identity
- Device Name
- KALEIDO MANDIBLE Crescent Dynamic Compression Plate,11.7*44.3mm,THK1.25mm,6Holes EUDAMED
- Model / Reference
- U shape bone plate EUDAMED2A1116031201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950292629660 EUDAMED
- Basic UDI-DI
- B-06950292629660 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 Crescent Dynamic Compression Plate, 11.7*44.3mm, THK1.25mm, 6H… 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-06950292629660 | 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 0b54147c-1d65-42dd-894b-3600e3828b31 61 fields · synced Jun 19, 2026