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Ultrasound Scanners
EUDAMEDClass IIa (EU MDR)
Ref Finus 65VRef Finus 50VRef Finus 55Ref Finus 60ProRef Finus 50Ref Finus 50ProRef Finus 60VRef Finus 85VRef Finus ScanRef Finus 55VRef Finus PlusRef Finus 90VRef Finus 90Ref Finus RevoRef Finus 60Ref Finus 70ExpRef Finus 90ProRef Finus LocRef Finus 80Ref Finus 45Ref Finus 45VRef Finus 90SicRef Finus 85ExpRef Finus 55ProRef Finus AlduRef Finus 65SicRef Finus 50SicRef Danus15V
Identity
- Trade Name
- Ultrasound Scanners EUDAMED
- Device Name
- Ultrasound Scanners EUDAMEDUltrasound Diagnostic System EUDAMED
- Model / Reference
- Finus 65V EUDAMEDFinus 50V EUDAMEDFinus 55 EUDAMEDFinus 60Pro EUDAMEDFinus 50 EUDAMEDFinus 50Pro EUDAMEDFinus 60V EUDAMEDFinus 85V EUDAMEDFinus Scan EUDAMEDFinus 55V EUDAMEDFinus Plus EUDAMEDFinus 90V EUDAMEDFinus 90 EUDAMEDFinus Revo EUDAMEDFinus 60 EUDAMEDFinus 70Exp EUDAMEDFinus 90Pro EUDAMEDFinus Loc EUDAMEDFinus 80 EUDAMEDFinus 45 EUDAMEDFinus 45V EUDAMEDFinus 90Sic EUDAMEDFinus 85Exp EUDAMEDFinus 55Pro EUDAMEDFinus Aldu EUDAMEDFinus 65Sic EUDAMEDFinus 50Sic EUDAMEDDanus15V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974676310883 EUDAMED06974676311026 EUDAMED16974676310286 EUDAMED06974676310890 EUDAMED16974676310279 EUDAMED06974676311002 EUDAMED06974676310913 EUDAMED06974676310722 EUDAMED06974676310791 EUDAMED06974676310982 EUDAMED06974676310784 EUDAMED06974676310678 EUDAMED06974676310647 EUDAMED06974676310807 EUDAMED16974676310293 EUDAMED16974676310316 EUDAMED06974676310654 EUDAMED06974676311071 EUDAMED06974676310746 EUDAMED16974676310262 EUDAMED06974676311064 EUDAMED06974676310661 EUDAMED06974676310685 EUDAMED06974676310968 EUDAMED06974676310944 EUDAMED06974676310876 EUDAMED06974676311019 EUDAMED06974676311279 EUDAMED
- Basic UDI-DI
- 697467631Finus97 EUDAMED697467631FF060702K4 EUDAMED
- Direct Marketing DI
- 06974676310883 EUDAMED06974676311026 EUDAMED16974676310286 EUDAMED06974676310890 EUDAMED16974676310279 EUDAMED06974676311002 EUDAMED06974676310913 EUDAMED06974676310722 EUDAMED06974676310791 EUDAMED06974676310982 EUDAMED06974676310784 EUDAMED06974676310678 EUDAMED06974676310647 EUDAMED06974676310807 EUDAMED16974676310293 EUDAMED16974676310316 EUDAMED06974676310654 EUDAMED06974676311071 EUDAMED06974676310746 EUDAMED16974676310262 EUDAMED06974676311064 EUDAMED06974676310661 EUDAMED06974676310685 EUDAMED06974676310968 EUDAMED06974676310944 EUDAMED06974676310876 EUDAMED06974676311019 EUDAMED
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMEDDenmark EUDAMEDPoland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultrasound Scanners by Focus&Fusion Healthcare (Hangzhou) Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697467631Finus97 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Focus&Fusion Healthcare (Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000017932
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (28)
- EUDAMED 2ad372cf-3cb5-4383-92fc-0c112924d728 61 fields · synced Oct 11, 2026
- EUDAMED 8dd79682-ffe7-492e-bd2e-31d96bebe2b3 61 fields · synced May 16, 2026
- EUDAMED b155e9f3-ba84-428d-8b63-1f91011ee4a1 61 fields · synced May 16, 2026
- EUDAMED c2367b0c-2b39-44e2-a962-fe2e31e99cc7 61 fields · synced May 16, 2026
- EUDAMED 2c83597b-8f1b-4102-b1df-08c169707fd5 61 fields · synced May 17, 2026
- EUDAMED 1812ad55-c450-45a0-9850-9e4027807d8b 61 fields · synced May 17, 2026
- EUDAMED feda5ba8-a460-48ab-a64a-5f583ec11f5b 61 fields · synced May 17, 2026
- EUDAMED 19fde887-831e-428e-86fa-aa414eda8062 61 fields · synced May 17, 2026
- EUDAMED 90ffdda6-e1ac-4c75-b265-3fb0d8b07cc6 61 fields · synced May 17, 2026
- EUDAMED d5e60ce0-c8cc-444f-a133-ee0d14ce2bba 61 fields · synced May 17, 2026
- EUDAMED dab92432-5c6a-4b44-9f21-29aa5b5c7879 61 fields · synced May 17, 2026
- EUDAMED b0c9bc6c-e9c6-4146-86b8-63c7c5abfd1c 61 fields · synced May 17, 2026
- EUDAMED c06e022d-96f0-4121-b4d1-dd7ac07f615f 61 fields · synced May 17, 2026
- EUDAMED 5ec7e1e1-aa78-4d78-8ab6-0154667d4556 61 fields · synced May 17, 2026
- EUDAMED 25073695-d397-4fc7-8cd8-23f9da8d9e58 61 fields · synced May 18, 2026
- EUDAMED ced9d67f-cf4a-4d20-8f8c-6bdbf1e967f5 61 fields · synced May 18, 2026
- EUDAMED 592d9cd9-ec28-46c1-9227-5708f0f0a186 61 fields · synced May 18, 2026
- EUDAMED 81fa5ddb-3c77-40ad-ac75-ac1b72eeca61 61 fields · synced May 18, 2026
- EUDAMED d9e856ca-281d-484d-95d7-d561ac179071 61 fields · synced May 18, 2026
- EUDAMED b3b4056c-69d2-4760-a887-2b4b17b246ad 61 fields · synced May 18, 2026
- EUDAMED 331e16b6-af2a-4f26-a0ce-11ccef8bddcd 61 fields · synced May 18, 2026
- EUDAMED d9cac5bb-418e-4f6c-8791-a2f315fefc33 61 fields · synced May 18, 2026
- EUDAMED 31fa065c-f286-4f5b-894a-ed652a756662 61 fields · synced May 18, 2026
- EUDAMED 4cd8010b-2c8e-416b-b92e-ca541f242077 61 fields · synced May 19, 2026
- EUDAMED 066a37fd-641b-4e4f-8d12-ce8d7d265867 61 fields · synced May 19, 2026
- EUDAMED b268b13f-e934-418d-8b11-87282553a6bc 61 fields · synced May 19, 2026
- EUDAMED 537790e0-2c31-4110-938f-e00c1a37e3cf 61 fields · synced May 19, 2026
- EUDAMED 927a42b9-9c99-4f6a-9e99-091fbf02dd15 61 fields · synced Jul 9, 2026