Identity
- Trade Name
- Diamond Bur EUDAMED
- Device Name
- Diamond Bur EUDAMED
- Model / Reference
- RT-27M EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970602034816 EUDAMED
- Basic UDI-DI
- B-06970602034816 EUDAMED
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Diamond Bur 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-06970602034816 | Class IIa | Active |
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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 21bbc76c-934e-4f3e-9b1b-f08a8de85463 61 fields · synced Oct 5, 2026