Identity
- Device Name
- TAEUS FLIP SYSTEM EUDAMED
- Model / Reference
- EN9000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++B931EN9000KY EUDAMED
- Basic UDI-DI
- B-++B931EN9000KY 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
Yes
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
Taeus Flip System by ENDRA Life Sciences, Inc. — 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-++B931EN9000KY | Class IIa | Active |
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Manufacturer
- Manufacturer
- ENDRA Life Sciences, Inc.
- EUDAMED SRN
- US-MF-000037148
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED a393c01f-dcdc-4b16-ac3f-c39c46b4d025 61 fields · synced Jun 19, 2026