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TripleAngled BA Excavator1.0mm
EUDAMEDClass I (EU MDR)
Ref 611-621SIModel Dental hand instrument, excavator for the removal of softened carious dentin
Identity
- Trade Name
- TripleAngled BA Excavator1.0mm EUDAMED
- Device Name
- Restorative hand instrument Ir EUDAMED
- Model / Reference
- Dental hand instrument, excavator for the removal of softened carious dentin EUDAMED611-621SI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311217338 EUDAMED
- Basic UDI-DI
- B-06438311217338 EUDAMED6438311RESTO1r0C6 EUDAMED
- Direct Marketing DI
- 06438311217338 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 Excavator1.0mm by LM-Instruments Oy — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438311217338 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438311217338 | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED ee519dc2-1083-455c-8f79-960ec2147d39 61 fields · synced Jul 28, 2026
- EUDAMED 50ebdbc3-dc75-4eae-bd8e-6d4bd1575338 61 fields · synced May 17, 2026