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Carbide burs
EUDAMEDClass I (EU MDR)
Ref Round:005Model Round:005、006、008、010、012、014、016、018、021、023; Inverted cone:006、008、010、012、014、016、018、021、023;, etc
Identity
- Device Name
- Carbide burs EUDAMED
- Model / Reference
- Round:005、006、008、010、012、014、016、018、021、023; Inverted cone:006、008、010、012、014、016、018、021、023;, etc EUDAMEDRound:005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977290910019 EUDAMED
- Basic UDI-DI
- 697729091CarbideBursHF 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
Carbide burs by Foshan Qiyang Medical Equipment Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Carbide dental bur, single-use.
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- 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 | 697729091CarbideBursHF | 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 deeb834f-936b-4233-aac2-a1d80182c990 61 fields · synced Jun 18, 2026