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Profile Reamer Drill
EUDAMEDClass IIa (EU MDR)
Ref I-SSR-40Ref I-SSR-65Ref I-SSR-50
by Novodent SA
Identity
- Trade Name
- Profile Reamer Drill EUDAMED
- Device Name
- Profile Reamer Drill EUDAMED
- Model / Reference
- I-SSR-40 EUDAMEDI-SSR-65 EUDAMEDI-SSR-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188202571 EUDAMED07630188202595 EUDAMED07630188202588 EUDAMED
- Basic UDI-DI
- B-07630188202571 EUDAMEDB-07630188202595 EUDAMEDB-07630188202588 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
Profile 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-07630188202571 | 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 ddb8dca3-0a2d-4a5e-a690-e0cfe6c96634 61 fields · synced Sep 18, 2026
- EUDAMED 3c8cc902-149b-43a8-b6a4-34bbc581df05 61 fields · synced May 18, 2026
- EUDAMED 94cd92ce-50ed-4291-9950-44b66408378a 61 fields · synced May 18, 2026