Identity
- Trade Name
- US 4000 (Ultrasound scanner) EUDAMED
- Device Name
- US 4000 EUDAMED
- Model / Reference
- 80-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260548935004 EUDAMED
- Basic UDI-DI
- B-04260548935004 EUDAMED
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - 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
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
US 4000 (Ultrasound scanner) by G. Heinemann Medizintechnik GmbH — 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-04260548935004 | Class IIa | Active |
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Manufacturer
- Manufacturer
- G. Heinemann Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000009705
Sources (1)
- EUDAMED 074e5346-452c-4a02-a354-82263ab6f986 61 fields · synced Jun 18, 2026