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Dental burs
EUDAMEDClass IIa (EU MDR)
Ref Low Speed Carbide Burs (welding) P0125012Model Low Speed Carbide Burs (welding)
Identity
- Device Name
- Dental burs EUDAMED
- Model / Reference
- Low Speed Carbide Burs (welding) EUDAMEDLow Speed Carbide Burs (welding) P0125012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978279634933 EUDAMED
- Basic UDI-DI
- 697827963DB003K5 EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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 WILSON (Shanghai) Medical Device 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 | 697827963DB003K5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- WILSON (Shanghai) Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000010527
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 137f2893-a579-47dd-8739-8782b0a83d21 61 fields · synced Jun 19, 2026