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Goldspeed Evo E16
EUDAMEDClass IIa (EU MDR)
Ref 76000976Model Dental handpieces and contra-angles
by CEFLA s.c.
Identity
- Trade Name
- Goldspeed Evo E16 EUDAMED
- Model / Reference
- Dental handpieces and contra-angles EUDAMED76000976 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837936596 EUDAMED
- Basic UDI-DI
- 803383793TRDENCONA001DH EUDAMED
- Direct Marketing DI
- 08033837936596 EUDAMED
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Goldspeed Evo E16 by CEFLA s.c. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803383793TRDENCONA001DH | Class IIa | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (1)
- EUDAMED b83d3295-00ca-4076-b611-4f0bc78b4bc7 61 fields · synced Jun 19, 2026