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KALEIDO 1.5mm Screw, self-tapping, 8mm
EUDAMEDClass IIb (EU MDR)
Ref 2A2220111508Model Self-tapping screwRef 2A2220111508S
by Shenzhen World Surgery Medical Device Technology Co., Ltd.
Identity
- Device Name
- KALEIDO 1.5mm Screw, self-tapping, 8mm EUDAMED
- Model / Reference
- Self-tapping screw EUDAMED2A2220111508 EUDAMED2A2220111508S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950292629738 EUDAMED06950292688056 EUDAMED
- Basic UDI-DI
- B-06950292629738 EUDAMEDB-06950292688056 EUDAMED
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
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
Category: Orthopaedic bone screw (non-sliding)
KALEIDO 1.5mm Screw, self-tapping, 8mm by Shenzhen World Surgery Medical Device Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED
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Also classified as Orthopaedic bone screw (non-sliding).
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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-06950292629738 | 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 1cf721ca-168d-4e9a-bc64-ac4e6e303b7d 61 fields · synced Jul 22, 2026
- EUDAMED ab1d54a8-0f45-4f98-b665-97c1d1f352d1 61 fields · synced May 18, 2026