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L-reamer Drill
EUDAMEDClass IIa (EU MDR)
Ref I-SIRL-60Ref I-SIRL-25Ref I-SIRL-50
by Novodent SA
Identity
- Trade Name
- L-reamer Drill EUDAMED
- Device Name
- L-reamer Drill EUDAMED
- Model / Reference
- I-SIRL-60 EUDAMEDI-SIRL-25 EUDAMEDI-SIRL-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188202564 EUDAMED07630188202496 EUDAMED07630188202540 EUDAMED
- Basic UDI-DI
- B-07630188202564 EUDAMEDB-07630188202496 EUDAMEDB-07630188202540 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
L-reamer Drill by Novodent SA — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07630188202564 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 0046b05d-1ed0-43b5-b8b1-382a7e92d622 61 fields · synced Jul 16, 2026
- EUDAMED e20f1c30-b959-44fd-8ba5-3c247bd05a51 61 fields · synced May 17, 2026
- EUDAMED 4b4be779-d103-4e77-8348-97ecbfa82629 61 fields · synced May 19, 2026