Identity
- Trade Name
- T8-3 EUDAMED
- Device Name
- TRANSDUCER, T8-3 EUDAMED
- Model / Reference
- TRANSDUCER, T8-3 EUDAMEDP31042-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517108250 EUDAMED
- Basic UDI-DI
- B-00841517108250 EUDAMED
- EMDN Code
- Z110402010302 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), MULTIDIMENSIONAL EUDAMED
Classification
- Device Class
- Class IIa 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
T8-3 by Fujifilm Sonosite, 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-00841517108250 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (1)
- EUDAMED 1bff65d3-fdd4-4d63-a6c2-a197daf5d575 61 fields · synced Jun 18, 2026