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Dental Burs
EUDAMEDClass I (EU MDR)
Ref Pro-5fModel 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 EUDAMEDPro-5f EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978203147218 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
Category: Carbide dental bur, single-use
Dental Burs by Shenzhen Americuras 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 | 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 90e0a5d6-4fda-40fb-a551-17591ef759fe 61 fields · synced Jun 18, 2026