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Wr
EUDAMEDClass I (EU MDR)
Ref 3015531303Model TF,TR,TC,FO,SF,SO,SR,RS,EX,BR,BC,DI,DI,WR,CR,CD,FG,RA,HP
Identity
- Trade Name
- WR EUDAMEDTR EUDAMEDSO EUDAMEDRS EUDAMED
- Device Name
- Dental Diamond Burs EUDAMED
- Model / Reference
- TF,TR,TC,FO,SF,SO,SR,RS,EX,BR,BC,DI,DI,WR,CR,CD,FG,RA,HP EUDAMED3015531303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975617282146 EUDAMED06975617282023 EUDAMED06975617282061 EUDAMED06975617282085 EUDAMED
- Basic UDI-DI
- 697561728BURST9 EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Carbide dental bur, single-use
Wr by Zhaoqing Gaoyao Recende Medical Equipment Co., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Carbide dental bur, single-use.
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- SSW CARBIDE — SS White Burs LLC · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- CYBERTECH — CB Healthcare Consulting GmbH · Class IIa
- 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 | 697561728BURST9 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhaoqing Gaoyao Recende Medical Equipment Co., LTD
- EUDAMED SRN
- CN-MF-000028095
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED f844fee4-5ba7-46a0-813d-91833d84fc75 61 fields · synced Oct 6, 2026
- EUDAMED 241f2274-7015-406c-ad42-43653cc362cf 61 fields · synced May 18, 2026
- EUDAMED 3d933f01-6882-4713-821c-89ad02bd75c1 61 fields · synced May 18, 2026
- EUDAMED 4291e08b-804a-4179-ae80-1b0d344815e0 61 fields · synced May 19, 2026