Identity
- Trade Name
- GYROFLEX LED EUDAMED
- Device Name
- GYROFEX EUDAMED
- Model / Reference
- RAPID COUPLING EUDAMED316.62.09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055727500045 EUDAMED
- Basic UDI-DI
- 805572750RAPIDCOUPLERBL EUDAMED
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Gyroflex Led by TeKne Dental srl — Class I — 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 | 805572750RAPIDCOUPLERBL | Class I | Active |
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Manufacturer
- Manufacturer
- TeKne Dental srl
- EUDAMED SRN
- IT-MF-000026680
Sources (1)
- EUDAMED 982e30f4-d389-497c-9d74-68bb23aef820 61 fields · synced Jul 8, 2026