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Elements Connect
EUDAMEDClass IIa (EU MDR)
Ref 815-1908Model Elements ConnectRef 815-1910
Identity
- Trade Name
- Elements Connect EUDAMED
- Device Name
- Cordless Endodontic Motor EUDAMED
- Model / Reference
- Elements Connect EUDAMED815-1908 EUDAMED815-1910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809455602232 EUDAMED08809455602751 EUDAMED
- Basic UDI-DI
- B-08809455602232 EUDAMEDB-08809455602751 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Elements Connect by Meta Systems Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809455602232 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Meta Systems Co., Ltd.
- EUDAMED SRN
- KR-MF-000022945
- Authorised Representative
- Meta Biomed Europe GmbH DE-AR-000004953
Sources (2)
- EUDAMED 2830228d-35a7-4880-99e7-1f29200634c7 61 fields · synced Jul 30, 2026
- EUDAMED 03a8f88d-3fad-4215-ab4f-bd63e171c865 61 fields · synced May 18, 2026