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Tungsten Carbide Bur
EUDAMEDClass I (EU MDR)
Ref V33-FG012CModel V33L-FGXL012C Tapered FissureRef V33L-FGXL016C ， Tapered Fissure, ISO：500 316 171 007 016，US.NO:702LModel V1-FGXL014C 、V1-FGXL016C、V33L-FGXL012C、V33L-FGXL016C、V33L-FG010C、V33L-FG012CRef V33L-FGXL016C
Identity
- Trade Name
- Tungsten Carbide Bur EUDAMED
- Device Name
- Tungsten Carbide Bur EUDAMED
- Model / Reference
- V33L-FGXL012C Tapered Fissure EUDAMEDV33-FG012C EUDAMEDV1-FGXL014C 、V1-FGXL016C、V33L-FGXL012C、V33L-FGXL016C、V33L-FG010C、V33L-FG012C EUDAMEDV33L-FGXL016C ， Tapered Fissure, ISO：500 316 171 007 016，US.NO:702L EUDAMEDV33L-FGXL016C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952367930497 EUDAMED06977493107490 EUDAMED06952367930466 EUDAMED
- Basic UDI-DI
- 69523679010031YJ EUDAMED697749310010031V7 EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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
Category: Carbide dental bur, single-use
Tungsten Carbide Bur by Shanghai Dochem Industries Co., Ltd. — 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 | 69523679010031YJ | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Dochem Industries Co., Ltd.
- EUDAMED SRN
- CN-MF-000014350
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED 51c891bc-c1f1-4991-8317-39c615240d75 61 fields · synced Aug 1, 2026
- EUDAMED 5c977615-830c-47bc-924d-d96b65cc4e74 61 fields · synced May 17, 2026
- EUDAMED 5e14971d-a178-4390-aeab-b47bc6ef9f07 61 fields · synced May 18, 2026
- EUDAMED 5c977615-830c-47bc-924d-d96b65cc4e74-1 61 fields · synced Jun 10, 2026