Diamond Bur
by Chengdu Sani Medical Equipment Co., Ltd. 15 variants
Ref /Model RI-6M, RC-1M, TH-19M, TH-7M, TH-S20M, RC-8M, RT-25M, OC-5M, FR-2M, TH-S15M, SF-4M, BR-6M, TH-20M, FT-3M, SF-6M, RC-9M, RT-22M, TH-4M, BR-2M, RT-6M, OC-8M, SS-8M, SF-5M, SF-8M, RT-26M, FT-5M, BR-8M, TH-S12M, BR-7M
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06970602034663 | Date11 Jul 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- RI-6M, /, RC-1M, TH-19M, TH-7M, TH-S20M, RC-8M, RT-25M, OC-5M, FR-2M, TH-S15M, SF-4M, BR-6M, TH-20M, FT-3M, SF-6M, RC-9M, RT-22M, TH-4M, BR-2M, RT-6M, OC-8M, SS-8M, SF-5M, SF-8M, RT-26M, FT-5M, BR-8M, TH-S12M, BR-7M
- Primary DI / UDI-DI
- 06970602034663, 06970602034267, 06970602034410, 06970602034700, 06970602034328, 06970602034366, 06970602034793, 06970602034212, 06970602034632, 06970602034335, 06970602034281, 06970602034298, 06970602034427, 06970602034755, 06970602034830, 06970602034373, 06970602034823, 06970602034779, 06970602034861, 06970602034250, 06970602034625, 06970602034854, 06970602034687, 06970602034847, 06970602034748, 06970602034229, 06970602034243, 06970602034786, 06970602034397
- Basic UDI-DI
- B-06970602034663, B-06970602034267, B-06970602034410, B-06970602034700, B-06970602034328, B-06970602034366, B-06970602034793, B-06970602034212, B-06970602034632, B-06970602034335, B-06970602034281, B-06970602034298, B-06970602034427, B-06970602034755, B-06970602034830, B-06970602034373, B-06970602034823, B-06970602034779, B-06970602034861, B-06970602034250, B-06970602034625, B-06970602034854, B-06970602034687, B-06970602034847, B-06970602034748, B-06970602034229, B-06970602034243, B-06970602034786, B-06970602034397
- EMDN Code
- L159007 Odontostomatology burs, reusable
- Device Class
- Class IIa
- EU market of registration
- BelgiumEstoniaBulgariaCroatiaFranceCzechiaDenmarkGermanyGreeceCyprus
Manufacturer details
- EUDAMED SRN
- CN-MF-000011715
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Chengdu Sani Medical Equipment Co., Ltd
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Properties
Other properties (8)
- Implantable: No
- Contains Latex: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No