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Dental Burs
EUDAMEDClass I (EU MDR)
Ref FG2-RA-331/2Model FG1-FG-1/4、FG1-FG-1/2、FG1-FG-1、 FG1-FG-2、FG1-FG-3、FG1-FG-4、 FG1-FG-5、FG1-FG-6、FG1-FG-7、 FG1-FG-8、FG1-RA-1/2、FG1-RA-1、 FG1-RA-2、FG1-RA-3、FG1-RA-4、 FG1-RA-5、FG1-RA-6、FG1-RA-7、etc
Identity
- Device Name
- Dental Burs EUDAMED
- Model / Reference
- FG1-FG-1/4、FG1-FG-1/2、FG1-FG-1、 FG1-FG-2、FG1-FG-3、FG1-FG-4、 FG1-FG-5、FG1-FG-6、FG1-FG-7、 FG1-FG-8、FG1-RA-1/2、FG1-RA-1、 FG1-RA-2、FG1-RA-3、FG1-RA-4、 FG1-RA-5、FG1-RA-6、FG1-RA-7、etc EUDAMEDFG2-RA-331/2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978203142992 EUDAMED
- Basic UDI-DI
- 697820314DBYR EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Dental Burs by Shenzhen Americuras 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 | 697820314DBYR | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Americuras Co., Ltd
- EUDAMED SRN
- CN-MF-000048352
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8e48ff1f-dcb9-4d4b-8ab7-a825834d0ec0 61 fields · synced Jun 18, 2026