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Endodontic Engine set
EUDAMEDClass IIa (EU MDR)
Ref ACL(B)-42EMRef E-CUBEModel E-CUBE(C/B) + CUBE EM + E-CUBE FOOT
Identity
- Trade Name
- Endodontic Engine set EUDAMED
- Device Name
- Endodontic Engine set EUDAMED
- Model / Reference
- ACL(B)-42EM EUDAMEDE-CUBE(C/B) + CUBE EM + E-CUBE FOOT EUDAMEDE-CUBE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809260475458 EUDAMED08809260474000 EUDAMED
- Basic UDI-DI
- B-08809260475458 EUDAMEDB-08809260474000 EUDAMED
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Electrical-only medical device connection cable, reusable
Endodontic Engine set by Saeshin Precision Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08809260475458 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Saeshin Precision Co., Ltd.
- EUDAMED SRN
- KR-MF-000016345
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (2)
- EUDAMED 5621f938-601d-49aa-abc4-52231ea2f23e 61 fields · synced Jul 30, 2026
- EUDAMED 19f10a04-0a35-4d40-ab39-5ca60fb9d467 61 fields · synced May 18, 2026