Identity
- Trade Name
- Cortex Bone Screw EUDAMED
- Device Name
- Cortex Bone Screw EUDAMED
- Model / Reference
- 100080060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942782455217 EUDAMED
- Basic UDI-DI
- B-06942782455217 EUDAMED
- EMDN Code
- P0912040102 AXIAL BONE FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Croatia 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
Cortex Bone Screw by Double Medical Technology Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942782455217 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- EUDAMED SRN
- CN-MF-000009048
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ae04930c-efb7-4dfa-b3df-1512543bd787 61 fields · synced Sep 17, 2026