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Diamond Burs
EUDAMEDClass I (EU MDR)
Ref G11-1535 FG series DD-1 FG，Yellow，ISO:257 018 FO-23EF，ISO：257 018Model G1-1113 G1-1133 G1-1143 G1-1153 G1-1163 G1-1233 G11-1533 G10-1813 G7-1113 G7-1223 1B4000-1B6910
Identity
- Trade Name
- Diamond Burs EUDAMED
- Device Name
- Diamond Burs EUDAMED
- Model / Reference
- G1-1113 G1-1133 G1-1143 G1-1153 G1-1163 G1-1233 G11-1533 G10-1813 G7-1113 G7-1223 1B4000-1B6910 EUDAMEDG11-1535 FG series DD-1 FG，Yellow，ISO:257 018 FO-23EF，ISO：257 018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493108244 EUDAMED
- Basic UDI-DI
- 697749310010029VL EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Diamond Burs 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 | 697749310010029VL | 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 (1)
- EUDAMED 2c177c56-8d67-4660-a4c5-6ecc5436195f 61 fields · synced Jun 18, 2026