Identity
- Trade Name
- X-Smart® Go Handpiece EUDAMED
- Device Name
- X-Smart Go Handpiece EUDAMED
- Model / Reference
- BSPXSGOAC0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D100BSPXSGOAC0010 EUDAMED
- Basic UDI-DI
- ++D100BSPXSGOAC0010TD EUDAMED
- Direct Marketing DI
- D100BSPXSGOAC0010 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
X-Smart® Go Handpiece by Forum Engineering Technologies (96) Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D100BSPXSGOAC0010TD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Forum Engineering Technologies (96) Ltd.
- EUDAMED SRN
- IL-MF-000023254
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED cba084b9-830e-4f63-94fa-b6a30fde6801 61 fields · synced Aug 2, 2026