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Gracey 11/12 Orbis
EUDAMEDClass I (EU MDR)
Ref 211-212PDOLMModel Dental hand instrument, curette for the removal of the subgingival and supragingival calculus
Identity
- Trade Name
- Gracey 11/12 Orbis EUDAMED
- Device Name
- Periodontal hand instrument EUDAMED
- Model / Reference
- 211-212PDOLM EUDAMEDDental hand instrument, curette for the removal of the subgingival and supragingival calculus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311706559 EUDAMED
- Basic UDI-DI
- 6438311PERIO1r06S EUDAMEDB-06438311706559 EUDAMED
- Direct Marketing DI
- 06438311706559 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 11/12 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 e7f9add5-a242-4a66-b152-2540eaa1d6b5 61 fields · synced Jul 23, 2026
- EUDAMED d45385b5-b949-4a4d-be51-c1fefb9aab24 61 fields · synced May 18, 2026