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McCall 13S-14S Orbis
EUDAMEDClass I (EU MDR)
Ref 222-223PDOLMModel Dental hand instrument, curette for the removal of the subgingival and supragingival calculus
Identity
- Trade Name
- McCall 13S-14S Orbis EUDAMED
- Device Name
- Periodontal hand instrument EUDAMED
- Model / Reference
- Dental hand instrument, curette for the removal of the subgingival and supragingival calculus EUDAMED222-223PDOLM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311706504 EUDAMED
- Basic UDI-DI
- B-06438311706504 EUDAMED6438311PERIO1r06S EUDAMED
- Direct Marketing DI
- 06438311706504 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
McCall 13S-14S 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 | B-06438311706504 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-06438311706504 | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED 0c314538-ad15-426b-ac09-521264e30a51 61 fields · synced Jul 15, 2026
- EUDAMED 53a55a4f-5a8c-499e-b5f2-1472bd3ad7d7 61 fields · synced May 16, 2026