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Gracey 13/14 Mini Orbis
EUDAMEDClass I (EU MDR)
Ref 213-214MPDOLMModel Dental hand instrument, curette for the removal of the subgingival and supragingival calculus
Identity
- Trade Name
- Gracey 13/14 Mini Orbis EUDAMED
- Device Name
- Periodontal hand instrument EUDAMED
- Model / Reference
- 213-214MPDOLM EUDAMEDDental hand instrument, curette for the removal of the subgingival and supragingival calculus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311706580 EUDAMED
- Basic UDI-DI
- 6438311PERIO1r06S EUDAMEDB-06438311706580 EUDAMED
- Direct Marketing DI
- 06438311706580 EUDAMED
- EMDN Code
- L159001 DENTAL AND PERIODONTAL CURETTES, 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
Gracey 13/14 Mini Orbis 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 | 6438311PERIO1r06S | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438311PERIO1r06S | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED 3baa86a3-59ea-4587-bbc5-b74c7b4f6f2d 61 fields · synced Jul 15, 2026
- EUDAMED 0dfdd5f4-a423-48b3-b317-9fb0a050d253 61 fields · synced May 11, 2026