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TripleAngled BA Excavator1.0mmDTS U
EUDAMEDClass I (EU MDR)
Ref 611-621ESTUModel Dental hand instrument, excavator for the removal of softened carious dentin
Identity
- Trade Name
- TripleAngled BA Excavator1.0mmDTS U EUDAMEDTripleAngled BA Excavator1.0mm DTS U EUDAMED
- Device Name
- Restorative hand instrument Ir EUDAMED
- Model / Reference
- 611-621ESTU EUDAMEDDental hand instrument, excavator for the removal of softened carious dentin EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311036298 EUDAMED
- Basic UDI-DI
- 6438311RESTO1r0C6 EUDAMEDB-06438311036298 EUDAMED
- Direct Marketing DI
- 06438311036298 EUDAMED
- EMDN Code
- L159002 DENTAL EXCAVATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
TripleAngled BA Excavator1.0mmDTS U by LM-Instruments Oy — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438311RESTO1r0C6 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438311RESTO1r0C6 | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED f6a12f81-186c-4314-bfe4-b2fc19e251f5 61 fields · synced Jul 13, 2026
- EUDAMED cd4a5d89-8366-4293-a96c-d02ab63e46dc 61 fields · synced May 18, 2026