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Diamond Burs
EUDAMEDClass I (EU MDR)
Ref Flat head cone typeModel Flat head cone type, Round head cone type, Pointed truncated cone type, Flame pointed head type, Flat head cylindrical type, Round head inverted cone type, Round ball type, etc
Identity
- Device Name
- Diamond Burs EUDAMED
- Model / Reference
- Flat head cone type, Round head cone type, Pointed truncated cone type, Flame pointed head type, Flat head cylindrical type, Round head inverted cone type, Round ball type, etc EUDAMEDFlat head cone type EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977290910002 EUDAMED
- Basic UDI-DI
- 697729091DiamondBursSV EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Carbide dental bur, single-use
Diamond Burs by Foshan Qiyang Medical Equipment Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Carbide dental bur, single-use.
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- SSW CARBIDE GREAT WHITE — SS White Burs LLC · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- DIAMOND BUR 1015C - Box with 10 — 3R Indústria E Comércio LTDA · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
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 | 697729091DiamondBursSV | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Qiyang Medical Equipment Limited
- EUDAMED SRN
- CN-MF-000040233
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED c87546dc-4b3c-46c2-9682-f4fe9a44f229 61 fields · synced Jun 18, 2026