Identity
- Trade Name
- ROOT ELEVATOR ANATOMIC HANDLE EUDAMED
- Device Name
- DENTAL ROOT ELEVATOR EUDAMED
- Model / Reference
- R-321-00 EUDAMEDR-322-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G276R321000J EUDAMED+G276R322000K EUDAMED
- Basic UDI-DI
- ++G276ROOTELEVATORSDA EUDAMED
- Direct Marketing DI
- +G276R321000J EUDAMED+G276R322000K EUDAMED
- EMDN Code
- L15900899 DENTAL EQUIPMENT TIPS NOT INCLUDED IN OTHER CLASSES, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Root Elevator Anatomic Handle by Seven Eight Sirgikal — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G276ROOTELEVATORSDA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Seven Eight Sirgikal
- EUDAMED SRN
- PK-MF-000009959
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED d44950ac-4e2f-4f56-8296-b8fd8f40ab68 61 fields · synced Jul 16, 2026
- EUDAMED 78d34e27-613c-4579-a6a6-0c0fcaf56d40 61 fields · synced May 17, 2026