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Hisense
EUDAMEDClass IIa (EU MDR)
Ref HD60EModel HD 20 series to HD 60 series,HD 80 series,H7 and Aisense seriesRef HD88ERef Aisense E60GRef HD42TRef HD78TRef HD45Ref HD50ERef HD85ERef HD62EXPRef HD80MRef HD35QRef HD85SRef HD40TRef HD59Ref HD85MRef HD78SRef HD86MRef HD70GRef HD42PlusRef HD50PlusRef HD78EXPRef HD72QRef HD40SRef HD20QRef HD40ERef HD40QRef HD82EXPRef HD86PlusRef HD25ProRef HD90Ref HD88EXPRef HD70SRef HD75PlusRef HD58Ref HD55QRef HD48GRef HD20ERef HD30ERef HD60QRef HD50TRef HD35PlusRef HD45PlusRef HD25ERef HD82ProRef HD70ProRef HD80EXPRef HD88SRef HD55ERef HD86Ref HD59PlusRef HD78Q
Identity
- Trade Name
- Hisense EUDAMED
- Device Name
- Ultrasound diagnostic systems HD 20 series to HD 60 series,Ultrasound diagnostic systems HD 80 series,Ultrasound diagnostic systems H7 and Aisense series EUDAMED
- Model / Reference
- HD 20 series to HD 60 series,HD 80 series,H7 and Aisense series EUDAMEDHD60E EUDAMEDHD88E EUDAMEDAisense E60G EUDAMEDHD42T EUDAMEDHD78T EUDAMEDHD45 EUDAMEDHD50E EUDAMEDHD85E EUDAMEDHD62EXP EUDAMEDHD80M EUDAMEDHD35Q EUDAMEDHD85S EUDAMEDHD40T EUDAMEDHD59 EUDAMEDHD85M EUDAMEDHD78S EUDAMEDHD86M EUDAMEDHD70G EUDAMEDHD42Plus EUDAMEDHD50Plus EUDAMEDHD78EXP EUDAMEDHD72Q EUDAMEDHD40S EUDAMEDHD20Q EUDAMEDHD40E EUDAMEDHD40Q EUDAMEDHD82EXP EUDAMEDHD86Plus EUDAMEDHD25Pro EUDAMEDHD90 EUDAMEDHD88EXP EUDAMEDHD70S EUDAMEDHD75Plus EUDAMEDHD58 EUDAMEDHD55Q EUDAMEDHD48G EUDAMEDHD20E EUDAMEDHD30E EUDAMEDHD60Q EUDAMEDHD50T EUDAMEDHD35Plus EUDAMEDHD45Plus EUDAMEDHD25E EUDAMEDHD82Pro EUDAMEDHD70Pro EUDAMEDHD80EXP EUDAMEDHD88S EUDAMEDHD55E EUDAMEDHD86 EUDAMEDHD59Plus EUDAMEDHD78Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978311950243 EUDAMED06978311951615 EUDAMED06978311952728 EUDAMED06978311950717 EUDAMED06978311952049 EUDAMED06978311950601 EUDAMED06978311950519 EUDAMED06978311951417 EUDAMED06978311950366 EUDAMED06978311951165 EUDAMED06978311950854 EUDAMED06978311951370 EUDAMED06978311950786 EUDAMED06978311950311 EUDAMED06978311951363 EUDAMED06978311952018 EUDAMED06978311951462 EUDAMED06978311951721 EUDAMED06978311950731 EUDAMED06978311950526 EUDAMED06978311951981 EUDAMED06978311951837 EUDAMED06978311950755 EUDAMED06978311951073 EUDAMED06978311950793 EUDAMED06978311950779 EUDAMED06978311951240 EUDAMED06978311951455 EUDAMED06978311950960 EUDAMED06978311951622 EUDAMED06978311951547 EUDAMED06978311951714 EUDAMED06978311951899 EUDAMED06978311950304 EUDAMED06978311950427 EUDAMED06978311950557 EUDAMED06978311951097 EUDAMED06978311950939 EUDAMED06978311950229 EUDAMED06978311950502 EUDAMED06978311950816 EUDAMED06978311950663 EUDAMED06978311951028 EUDAMED06978311951233 EUDAMED06978311951677 EUDAMED06978311951141 EUDAMED06978311951578 EUDAMED06978311950441 EUDAMED06978311951424 EUDAMED06978311950342 EUDAMED06978311952032 EUDAMED
- Basic UDI-DI
- 697831195Ultrasound9F EUDAMED
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMEDZ11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Hisense by Qingdao Hisense Medical 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 | 697831195Ultrasound9F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Qingdao Hisense Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000047224
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (51)
- EUDAMED 3c91d6cb-4548-422e-bdbc-4b77730f561d 61 fields · synced Oct 6, 2026
- EUDAMED 82413a00-d82c-4fb9-bf29-3c3ee8806da8 61 fields · synced May 11, 2026
- EUDAMED f4a53495-b191-42a5-a3cd-077db3ac05e6 61 fields · synced May 11, 2026
- EUDAMED f560a3be-7564-4dbe-8ac5-c59df4939fb0 61 fields · synced May 11, 2026
- EUDAMED 00d3dbf7-8c62-4534-9f20-b5b6bf833208 61 fields · synced May 11, 2026
- EUDAMED 07697612-ec9f-46b8-bbe8-4cb9936453f4 61 fields · synced May 11, 2026
- EUDAMED 0f9d4452-8243-4278-9dd3-d75558afc07a 61 fields · synced May 11, 2026
- EUDAMED 16a1a343-f7f8-4fed-b0de-54b0bcd6e3a6 61 fields · synced May 11, 2026
- EUDAMED e545e995-3818-4417-aef4-30df0812a023 61 fields · synced May 16, 2026
- EUDAMED d4aadece-cfef-4cff-b749-38b8c7c3a35d 61 fields · synced May 16, 2026
- EUDAMED 43a5c7b5-a33f-43c1-a102-9d4e001c147d 61 fields · synced May 16, 2026
- EUDAMED 2a3080d9-92b8-4d74-815a-135f5c46c7a7 61 fields · synced May 16, 2026
- EUDAMED aab1eb12-2fe5-4a49-afd5-aebcd7fb2647 61 fields · synced May 16, 2026
- EUDAMED 95733611-1d5f-474a-a670-ae0d83fcdb2b 61 fields · synced May 16, 2026
- EUDAMED 3eb362bb-2fb7-4420-954a-6d5b3fdb25a1 61 fields · synced May 16, 2026
- EUDAMED 3db94a95-ecb5-4bac-8fe9-6bd8c564161b 61 fields · synced May 16, 2026
- EUDAMED d0b0ce84-37f1-4d45-99b9-42f2b45e1d71 61 fields · synced May 16, 2026
- EUDAMED 2f9ac073-4ee6-4509-81ec-71f6e43af9b4 61 fields · synced May 16, 2026
- EUDAMED 09b38fa4-88b8-4769-8219-8807e8c147f3 61 fields · synced May 16, 2026
- EUDAMED 9dc7442e-4a0b-4102-b5a3-e48f72648909 61 fields · synced May 16, 2026
- EUDAMED dbf97968-c4ad-4b3c-aaa4-7e94dda09bfe 61 fields · synced May 16, 2026
- EUDAMED af127746-4dae-4754-af73-8e4c5e69555a 61 fields · synced May 16, 2026
- EUDAMED b64ab9c2-4dad-46c4-aa13-26e4cad8bf87 61 fields · synced May 16, 2026
- EUDAMED 23514ca8-1533-4896-86b7-0587533b3461 61 fields · synced May 16, 2026
- EUDAMED 81205a9e-2b3e-429d-96cf-ea3c7ea73f4a 61 fields · synced May 16, 2026
- EUDAMED fd6de17f-a62f-45f5-acd0-4e907d0c7802 61 fields · synced May 17, 2026
- EUDAMED e25d16db-7451-403a-965d-49d2581e2bf6 61 fields · synced May 17, 2026
- EUDAMED 12deffdc-fa04-4813-a65a-6d58f9603116 61 fields · synced May 17, 2026
- EUDAMED 4b4e65f8-c58b-4501-8aa9-ec1b1e204635 61 fields · synced May 17, 2026
- EUDAMED 0ab5cbf5-8b25-4a91-aa33-05648cb1b6a7 61 fields · synced May 17, 2026
- EUDAMED 8c989371-0134-47e8-88f7-d22a78224e38 61 fields · synced May 17, 2026
- EUDAMED b894d678-3881-460f-84bc-99689dc0ad7f 61 fields · synced May 17, 2026
- EUDAMED eb67dd4c-5cac-4d5c-8932-3743ae67bc75 61 fields · synced May 17, 2026
- EUDAMED 79eb2ad9-bc69-4147-bedf-ca12f6c300a4 61 fields · synced May 17, 2026
- EUDAMED 599467ee-b7ec-4f3e-af9c-68e55802b0be 61 fields · synced May 17, 2026
- EUDAMED c71e675c-95f9-469b-a4ad-b8cc8b61ca84 61 fields · synced May 17, 2026
- EUDAMED 0158ec57-33d6-4b20-a34d-76a3735a103a 61 fields · synced May 17, 2026
- EUDAMED ec226769-9478-44f2-b942-e0b49f01e9e1 61 fields · synced May 17, 2026
- EUDAMED 7abd4b68-53d7-41da-90a5-7a797df3673f 61 fields · synced May 17, 2026
- EUDAMED c1d48857-5450-415f-a811-a5211c775d8c 61 fields · synced May 17, 2026
- EUDAMED 8d69b635-96cc-4f19-806f-91f4e53bda41 61 fields · synced May 17, 2026
- EUDAMED 327a1d23-7da8-421d-a608-7833b3d09e98 61 fields · synced May 17, 2026
- EUDAMED b490736f-5e53-45f1-9384-2b8f41be05ae 61 fields · synced May 17, 2026
- EUDAMED 2e31ee93-0f07-4a98-930c-c6bf981cecbc 61 fields · synced May 17, 2026
- EUDAMED ac3fa04f-593f-44ef-8308-2978df4a331c 61 fields · synced May 17, 2026
- EUDAMED 790e599c-09fc-4abb-ba9c-2506aad3676e 61 fields · synced May 17, 2026
- EUDAMED a7830d84-8ade-463f-8ebe-70ab606c6634 61 fields · synced May 17, 2026
- EUDAMED 3cfe6a3e-ff53-49b3-a3ed-deb05dea6c8d 61 fields · synced May 17, 2026
- EUDAMED ee11f9d3-aa30-4fc2-bc20-51214fe2e142 61 fields · synced May 17, 2026
- EUDAMED feff4b4c-a197-400e-8cce-52f50e0f2ce3 61 fields · synced May 17, 2026
- EUDAMED 88fb74cf-ed9c-47c5-acbb-4aec38ad3cd7 61 fields · synced May 17, 2026