Identity
- Trade Name
- VFLS EUDAMED
- Device Name
- 5.0 mm Variable Fixation Locking Screw - titanium EUDAMED
- Model / Reference
- S5400KKS EUDAMEDS540032S - S540070S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CHMF000021985S5400KKSTW EUDAMED
- Basic UDI-DI
- B-CHMF000021985S5400KKSTW EUDAMED
- EMDN Code
- P09120402 SCREWS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Vfls by Biomech Innovations AG — Class III — 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-CHMF000021985S5400KKSTW | Class III | Active |
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Manufacturer
- Manufacturer
- Biomech Innovations AG
- EUDAMED SRN
- CH-MF-000021985
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED fd9a9d87-9f6b-4aea-9828-e8b81ddfe63b 61 fields · synced Jul 29, 2026