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Dental Burs
EUDAMEDClass IIa (EU MDR)
Ref SFModel BR, BC, SI, DI, WR, SF, TF, SR, TR, EX, SO, FO
Identity
- Trade Name
- Dental Burs EUDAMED
- Device Name
- Dental Burs EUDAMED
- Model / Reference
- BR, BC, SI, DI, WR, SF, TF, SR, TR, EX, SO, FO EUDAMEDSF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976042350080 EUDAMED
- Basic UDI-DI
- 697604235000HQ EUDAMED
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
Dental Burs by Guangdong Rotary Art Equipment Co., Ltd. — 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 | 697604235000HQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Rotary Art Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000032269
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 6c905f1b-8b41-47a0-8656-ff6912e280da 61 fields · synced Jun 17, 2026