Identity
- Trade Name
- EMP EUDAMED
- Device Name
- Full Digital Ultrasound Diagnostic Device EUDAMED
- Model / Reference
- N5 EUDAMEDEMP N5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974857390178 EUDAMED
- Basic UDI-DI
- B-06974857390178 EUDAMED
- 510(k) Number
- K081873 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Emp by Shenzhen Emperor Electronic Technology Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081873 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06974857390178 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Emperor Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020035
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 0c2f2b93-2f64-4e9f-a28d-ff7ff9207d0d 61 fields · synced Jul 13, 2026
- FDA 510(k) K081873 24 fields · synced May 18, 2026