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Tungsten carbide bur
EUDAMEDClass I (EU MDR)
Ref V1-FGXL016C FG XL, Round, ISO：500 316 001 001 016，US.NO:5Model 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 EUDAMEDV1-FGXL016C FG XL, Round, ISO：500 316 001 001 016，US.NO:5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493107476 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
Tungsten carbide bur by Shanghai Dochem Industries Co., Ltd. — Class I — 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 | 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 12d1f08a-c92d-48a5-8b1f-3cc5c4c989a8 61 fields · synced Oct 8, 2026
- EUDAMED 12d1f08a-c92d-48a5-8b1f-3cc5c4c989a8-1 61 fields · synced Jun 10, 2026