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KALEIDO MANDIBLE Adaption Plate, 5.2*71.2mm, Thickness 1.25mm, 12 Holes
EUDAMEDClass IIb (EU MDR)
Ref 2A1114071201Model Straight bone plate
by Shenzhen World Surgery Medical Device Technology Co., Ltd.
Identity
- Device Name
- KALEIDO MANDIBLE Adaption Plate, 5.2*71.2mm, Thickness 1.25mm, 12 Holes EUDAMED
- Model / Reference
- Straight bone plate EUDAMED2A1114071201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950292630109 EUDAMED
- Basic UDI-DI
- B-06950292630109 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 Adaption Plate, 5.2*71.2mm, Thickness 1.25mm, 12 Holes by Shenzhen World Surgery Medical Device Technology Co., Ltd. — Class IIb — MDD…
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-06950292630109 | 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 b9b01f49-f02b-4bfa-9fec-7c7067a2cb50 61 fields · synced Oct 6, 2026