Identity
- Trade Name
- SE3133 EUDAMED
- Device Name
- SE3133 EUDAMEDEndocavity EUDAMED
- Model / Reference
- 1210000034 EUDAMED120000034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304452955 EUDAMED
- Basic UDI-DI
- B-08056304452955 EUDAMED805630445ESA.PR0000005.SX EUDAMED
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Se3133 by Esaote S.p.A. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08056304452955 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304452955 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED e2e534d4-0e36-4178-96b6-2bf0f30751c0 61 fields · synced Jul 11, 2026
- EUDAMED d877d208-db6e-4a34-b0b7-8602aaa52cf2 61 fields · synced May 17, 2026