Identity
- Trade Name
- EVO 500K TL EUDAMED
- Device Name
- Dental High Speed Handpiece EUDAMED
- Model / Reference
- 08010101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719878530477 EUDAMED
- Basic UDI-DI
- 471987853HighSpeedSS EUDAMED
- Direct Marketing DI
- 04719878530477 EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Evo 500k Tl by Ttbio Corp. — 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 | 471987853HighSpeedSS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ttbio Corp.
- EUDAMED SRN
- TW-MF-000001916
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4878e98a-05de-474e-8125-d47ecc9e501e 61 fields · synced Jul 18, 2026