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Tungsten carbide bur
EUDAMEDClass I (EU MDR)
Ref V33L-FG010C, FG, Long Tapered Fissure, ISO：500 314 171 007 010，US.NO:700LModel V1-FGXL014C 、V1-FGXL016C、V33L-FGXL012C、V33L-FGXL016C、V33L-FG010C、V33L-FG012C
Identity
- Trade Name
- Tungsten carbide bur EUDAMED
- Device Name
- Tungsten carbide bur EUDAMED
- Model / Reference
- V1-FGXL014C 、V1-FGXL016C、V33L-FGXL012C、V33L-FGXL016C、V33L-FG010C、V33L-FG012C EUDAMEDV33L-FG010C, FG, Long Tapered Fissure, ISO：500 314 171 007 010，US.NO:700L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493107506 EUDAMED
- Basic UDI-DI
- 697749310010031V7 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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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 | 697749310010031V7 | 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 (2)
- EUDAMED bb15a365-19d9-4067-b325-79f84691ac18 61 fields · synced Jul 10, 2026
- EUDAMED bb15a365-19d9-4067-b325-79f84691ac18-1 61 fields · synced Jun 9, 2026