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elements IC
EUDAMEDClass IIa (EU MDR)
Ref 973-0602-TYPE FModel elements ICRef 973-0604-TYPE F
Identity
- Trade Name
- elements IC EUDAMED
- Device Name
- Endodontic Obturation System EUDAMED
- Model / Reference
- elements IC EUDAMED973-0602-TYPE F EUDAMED973-0604-TYPE F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809455602140 EUDAMED08809455602157 EUDAMED
- Basic UDI-DI
- B-08809455602140 EUDAMEDB-08809455602157 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING 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 IC 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-08809455602140 | 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 371d2282-c277-4248-8e0a-7085b660ec8f 61 fields · synced Jul 13, 2026
- EUDAMED ff630305-e0da-44fa-b834-d1e32deb20de 61 fields · synced May 17, 2026