Helical Drill 3, 0x11, 5mm Sleeve 4, 3 Guide
by Systhex Sistemas De Implantes Ósseo Integrado Ltda
Ref 805130
Active
CE MDR 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/MDR | NumberB-*+D99480513007* *+D99480513007* | Date11 Dec 2024 | StatusActive |
| European Union | CE/MDD | NumberB-*+D99480513007* *+D99480513007* | Date11 Dec 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- DRILL's
- Model / Reference
- 805130
- Primary DI / UDI-DI
- *+D99480513007*
- Basic UDI-DI
- B-*+D99480513007*, ++D994DRILL93
- EMDN Code
- Q010399 Surgical dental devices - other
- Device Class
- Class IIa
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- BR-MF-000043219
- Authorised representative
- SBP PORTUGAL LDA PT-AR-000042998
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Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No