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KALEIDO MANDIBLE Straight Plate, 6.8*46.8mm, Thickness 1.5mm, 6 Holes
EUDAMEDClass IIb (EU MDR)
Ref 2A1114071501SModel Straight bone plateRef 2A1114071501
by Shenzhen World Surgery Medical Device Technology Co., Ltd.
Identity
- Device Name
- KALEIDO MANDIBLE Straight Plate, 6.8*46.8mm, Thickness 1.5mm, 6 Holes EUDAMED
- Model / Reference
- Straight bone plate EUDAMED2A1114071501S EUDAMED2A1114071501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950292688148 EUDAMED06950292630116 EUDAMED
- Basic UDI-DI
- B-06950292688148 EUDAMEDB-06950292630116 EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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 Straight Plate, 6.8*46.8mm, Thickness 1.5mm, 6 Holes by Shenzhen World Surgery Medical Device Technology Co., Ltd. — Class IIb — MDD — listed…
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-06950292688148 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000017319
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 47d5cae4-0d6e-40ed-9627-68e1f461eff6 61 fields · synced Oct 7, 2026
- EUDAMED 084b64fb-7eab-4780-94e4-f09267caa93b 61 fields · synced May 17, 2026