Identity
- Trade Name
- P2 5-13 EUDAMED
- Device Name
- P2 5-13 EUDAMEDPhased Array / High and Ultra High Frequency EUDAMED
- Model / Reference
- 120000044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056304453082 EUDAMED
- Basic UDI-DI
- B-08056304453082 EUDAMED805630445ESA.PR0000013.SW EUDAMED
- EMDN Code
- Z110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL EUDAMEDZ110402010302 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), MULTIDIMENSIONAL 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
P2 5-13 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-08056304453082 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304453082 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (2)
- EUDAMED 7a4736bc-23e1-4278-8f60-6415ca1dfe12 61 fields · synced Jul 9, 2026
- EUDAMED beb48db8-9922-49c0-a13d-022c71bc099e 61 fields · synced May 19, 2026