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Ultrasound Probes
EUDAMEDClass IIa (EU MDR)
Ref C5-2Ref P4-1Ref L13-3Ref V5-2Ref L12-5Ref EC8-4Ref P5-2Ref L17-5Ref EC10-3Ref L12-4Ref V6-2Ref C6-1SRef L12-4GRef EC11-3Ref L15-3Ref L14-3LSRef L12-4RCRef B15-4Ref ECL10-4Ref PT5-CW
Identity
- Trade Name
- ULTRASOUND PROBES EUDAMED
- Device Name
- ULTRASOUND PROBES EUDAMED
- Model / Reference
- C5-2 EUDAMEDP4-1 EUDAMEDL13-3 EUDAMEDV5-2 EUDAMEDL12-5 EUDAMEDEC8-4 EUDAMEDP5-2 EUDAMEDL17-5 EUDAMEDEC10-3 EUDAMEDL12-4 EUDAMEDV6-2 EUDAMEDC6-1S EUDAMEDL12-4G EUDAMEDEC11-3 EUDAMEDL15-3 EUDAMEDL14-3LS EUDAMEDL12-4RC EUDAMEDB15-4 EUDAMEDECL10-4 EUDAMEDPT5-CW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974676310012 EUDAMED06974676310098 EUDAMED06974676310074 EUDAMED06974676310166 EUDAMED06974676310050 EUDAMED06974676310135 EUDAMED06974676310081 EUDAMED06974676310067 EUDAMED06974676310142 EUDAMED06974676310043 EUDAMED06974676310159 EUDAMED06974676310029 EUDAMED06974676311132 EUDAMED06974676311194 EUDAMED06974676311149 EUDAMED06974676311170 EUDAMED06974676311187 EUDAMED06974676312702 EUDAMED06974676311903 EUDAMED06974676311217 EUDAMED
- Basic UDI-DI
- 697467631ConvexNW EUDAMED697467631PhasedM8 EUDAMED697467631LinearM4 EUDAMED697467631VolumeVL EUDAMED697467631IntracavityFJ EUDAMED
- Direct Marketing DI
- 06974676310012 EUDAMED06974676310098 EUDAMED06974676310074 EUDAMED06974676310166 EUDAMED06974676310050 EUDAMED06974676310135 EUDAMED06974676310081 EUDAMED06974676310067 EUDAMED06974676310142 EUDAMED06974676310043 EUDAMED06974676310159 EUDAMED06974676310029 EUDAMED
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMEDZ110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL EUDAMEDZ110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMEDZ110402010202 CURVILINEAR TRANSCUTANEOUS MULTIDIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMEDZ1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMEDZ110402010302 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), MULTIDIMENSIONAL EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Extracorporeal ultrasound imaging transducer, hand-held
Ultrasound Probes by Focus&Fusion Healthcare (Hangzhou) Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697467631ConvexNW | 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 (20)
- EUDAMED ffc422a6-d4c8-4f72-856d-20da6f9e2271 61 fields · synced Oct 6, 2026
- EUDAMED 558151fb-f7ed-4486-b29e-c72cc915bb29 61 fields · synced May 16, 2026
- EUDAMED d33dac2c-7487-44ff-917e-b0401509f265 61 fields · synced May 16, 2026
- EUDAMED ca6979d3-4cee-448a-bf93-223dabf21216 61 fields · synced May 16, 2026
- EUDAMED b67ac100-41ee-4abd-af7c-c95d9f75e74c 61 fields · synced May 17, 2026
- EUDAMED f1c45a6c-0602-4a4b-aeb2-8cf02e6c25ca 61 fields · synced May 17, 2026
- EUDAMED 334bdef7-dc72-4320-8258-edd7277854b7 61 fields · synced May 17, 2026
- EUDAMED 2e0a779a-32b0-4e16-bdce-6f3030fa69a8 61 fields · synced May 18, 2026
- EUDAMED 13050dee-aa02-4db8-b3b8-20c3e4096005 61 fields · synced May 18, 2026
- EUDAMED d69e5a6a-1858-4764-b096-bd1f36d7ecce 61 fields · synced May 18, 2026
- EUDAMED ab73141f-f7ef-429e-883e-b009d2726b89 61 fields · synced May 18, 2026
- EUDAMED cc2456f7-a9ad-492a-b746-16994b90aa68 61 fields · synced May 19, 2026
- EUDAMED 6cac54f8-e5c4-4155-b0b6-d322ea43be60 61 fields · synced Jun 20, 2026
- EUDAMED b7e0002f-8739-44d9-8ec3-7768d9ef1078 61 fields · synced Jul 9, 2026
- EUDAMED 2e3d47a0-8b16-449a-8bc4-5b30a4b6e8db 61 fields · synced Jul 21, 2026
- EUDAMED 8cf180f0-155c-4115-b034-058d94c63091 61 fields · synced Jul 23, 2026
- EUDAMED f306dfa7-25c3-4c7a-b35b-5601626cff8d 61 fields · synced Jul 24, 2026
- EUDAMED b3e47f5a-5190-4c5c-b8e2-56de925af7d1 61 fields · synced Jul 24, 2026
- EUDAMED b2d56d87-8564-48b1-9f56-b93fef6f44b5 61 fields · synced Jul 30, 2026
- EUDAMED eb767057-23da-4778-bbe1-5b342fc4ff53 61 fields · synced Jul 30, 2026