Identity
- Trade Name
- Dental Endo Motor EUDAMED
- Device Name
- Carbide Bur EUDAMED
- Model / Reference
- FG—1159 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974242193261 EUDAMED
- Basic UDI-DI
- B-06974242193261 EUDAMED
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Dental Endo Motor by Chengdu Sani Medical Equipment Co., Ltd — Class IIa — 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-06974242193261 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chengdu Sani Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000011715
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d229817b-50f0-41ab-9fc1-c7b263b4076d 61 fields · synced Jun 20, 2026