Identity
- Trade Name
- Dental Scalers EUDAMED
- Device Name
- Dental Scalers EUDAMED
- Model / Reference
- 70-941 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004479953 EUDAMED
- Basic UDI-DI
- 896400317100769 EUDAMED
- EMDN Code
- L159009 ODONTOSTOMATOLOGY SCALERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Dental Scalers by Formed Surgical Instruments — 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 | 896400317100769 | Class I | Active |
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Manufacturer
- Manufacturer
- Formed Surgical Instruments
- EUDAMED SRN
- PK-MF-000011695
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED b96e456e-20d9-4f59-942d-0590dbf8acd1 61 fields · synced Jul 31, 2026