Identity
- Trade Name
- COLUMBIA SCALER EUDAMED
- Device Name
- COLUMBIA SCALER EUDAMED
- Model / Reference
- S-301-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G276S301020K EUDAMED
- Basic UDI-DI
- ++G276SCALERS3U EUDAMED
- EMDN Code
- L159009 ODONTOSTOMATOLOGY SCALERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Columbia Scaler 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 | ++G276SCALERS3U | Class I | Active |
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Manufacturer
- Manufacturer
- Seven Eight Sirgikal
- EUDAMED SRN
- PK-MF-000009959
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4cc693ca-4cfe-41c6-a72f-266b897d2876 61 fields · synced Jun 18, 2026