Identity
- Trade Name
- SYNCHRO QS4 EUDAMED
- Device Name
- SYNCHRO QS4 EUDAMED
- Model / Reference
- M109A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034108510347 EUDAMED
- Basic UDI-DI
- B-08034108510347 EUDAMED
- EMDN Code
- Z12011080 LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Synchro Qs4 by Deka M.e.l.a. Srl — 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-08034108510347 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Deka M.e.l.a. Srl
- EUDAMED SRN
- IT-MF-000007389
Sources (1)
- EUDAMED 24f40e01-818c-43fe-be2d-2e01dfc9008d 61 fields · synced Jul 31, 2026