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Dental Burs
EUDAMEDClass I (EU MDR)
Ref FO-33EFModel 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、etcRef EX-35Ref MI-S45Ref Pro-S3Ref TC-23FRef TF-42CRef CR-11EFRef TR-15SCRef FG21-HP-59Ref TC-26CRef EX-29EFRef EX-32Ref SI-47Ref FG31-RA-559LRef FG31-FG-562Ref SI-045Ref Pro-1EFRef FG31-RA-558Ref CE-15EFRef EX-53Ref FG2-RA-37Ref FO-42EFRef CE-16EFRef EX-21CRef TR-S13CRef FG2-FG-41Ref FG21-RA-59LRef FG21R-FG-1158Ref ENDO Z151-FG-016Ref FG2-FG-39Ref TF-41CRef FG33-RA-700LRef SR-11SCRef FG31-HP-557Ref FO-22EFRef TR-23Ref TR-25FRef SI-44Ref BC-31CRef TF-31SCRef SO-20Ref EX-21FRef SR-12SCRef TF-22Ref FG33-FG-701LRef TC-24Ref SR-55Ref FO-21EFRef TF-31CRef SI-S46Ref SI-47C
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 EUDAMEDFO-33EF EUDAMEDEX-35 EUDAMEDMI-S45 EUDAMEDPro-S3 EUDAMEDTC-23F EUDAMEDTF-42C EUDAMEDCR-11EF EUDAMEDTR-15SC EUDAMEDFG21-HP-59 EUDAMEDTC-26C EUDAMEDEX-29EF EUDAMEDEX-32 EUDAMEDSI-47 EUDAMEDFG31-RA-559L EUDAMEDFG31-FG-562 EUDAMEDSI-045 EUDAMEDPro-1EF EUDAMEDFG31-RA-558 EUDAMEDCE-15EF EUDAMEDEX-53 EUDAMEDFG2-RA-37 EUDAMEDFO-42EF EUDAMEDCE-16EF EUDAMEDEX-21C EUDAMEDTR-S13C EUDAMEDFG2-FG-41 EUDAMEDFG21-RA-59L EUDAMEDFG21R-FG-1158 EUDAMEDENDO Z151-FG-016 EUDAMEDFG2-FG-39 EUDAMEDTF-41C EUDAMEDFG33-RA-700L EUDAMEDSR-11SC EUDAMEDFG31-HP-557 EUDAMEDFO-22EF EUDAMEDTR-23 EUDAMEDTR-25F EUDAMEDSI-44 EUDAMEDBC-31C EUDAMEDTF-31SC EUDAMEDSO-20 EUDAMEDEX-21F EUDAMEDSR-12SC EUDAMEDTF-22 EUDAMEDFG33-FG-701L EUDAMEDTC-24 EUDAMEDSR-55 EUDAMEDFO-21EF EUDAMEDTF-31C EUDAMEDSI-S46 EUDAMEDSI-47C EUDAMED
Identifiers
- Primary DI / UDI-DI
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- 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 (51)
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