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i-reamer Drill
EUDAMEDClass IIa (EU MDR)
Ref I-SIR-35Ref I-SIR-45Ref I-SIR-30Ref I-SIR-55Ref I-SIR-40Ref I-SIR-50
by Novodent SA
Identity
- Trade Name
- i-reamer Drill EUDAMED
- Device Name
- i-reamer Drill EUDAMED
- Model / Reference
- I-SIR-35 EUDAMEDI-SIR-45 EUDAMEDI-SIR-30 EUDAMEDI-SIR-55 EUDAMEDI-SIR-40 EUDAMEDI-SIR-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188202434 EUDAMED07630188202458 EUDAMED07630188202427 EUDAMED07630188202472 EUDAMED07630188202441 EUDAMED07630188202465 EUDAMED
- Basic UDI-DI
- B-07630188202434 EUDAMEDB-07630188202458 EUDAMEDB-07630188202427 EUDAMEDB-07630188202472 EUDAMEDB-07630188202441 EUDAMEDB-07630188202465 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
i-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-07630188202434 | 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 (6)
- EUDAMED b32d8f68-55c8-4574-a5af-3b1185e1d372 61 fields · synced Jul 29, 2026
- EUDAMED 209b8b7b-6c4b-43a0-a514-b6b256405499 61 fields · synced May 16, 2026
- EUDAMED 974e99d7-ac99-4442-a292-24170a8cffd2 61 fields · synced May 17, 2026
- EUDAMED 8742b274-a211-4caf-ab05-4341afab1275 61 fields · synced May 17, 2026
- EUDAMED cfb371ec-a770-4ab8-8182-2b52c48de58e 61 fields · synced May 17, 2026
- EUDAMED de18a360-d414-42ed-8bae-d4ba9d26ad0d 61 fields · synced May 18, 2026