Identity
- Trade Name
- EMP EUDAMED
- Device Name
- Full Digital Ultrasound Diagnostic Device EUDAMED
- Model / Reference
- N2 EUDAMEDEMP N2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974857390222 EUDAMED
- Basic UDI-DI
- B-06974857390222 EUDAMED
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Emp by Shenzhen Emperor Electronic Technology 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-06974857390222 | 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 (1)
- EUDAMED cb65a0f5-714b-4253-af7f-69d03a16403f 61 fields · synced May 23, 2026