Identity
- Trade Name
- EX-11 EUDAMED
- Device Name
- Dental Diamond Burs EUDAMED
- Model / Reference
- Series EUDAMEDQ0199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975909342091 EUDAMED
- Basic UDI-DI
- 697590934BURWX EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ex-11 by Foshan Toye Dental Equipment Co., Ltd — 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 | 697590934BURWX | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Toye Dental Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000022808
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4c2bd7cf-8201-4848-bfae-660a0296993f 61 fields · synced Jul 12, 2026