24 results
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56ms
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Sources: EU EUDAMED, US FDA
Caris Life Sciences
Manufacturer
🇺🇸 United States
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.
FDA Enforcement
Class II
·Ongoing·CARIS LIFE SCIENCES·September 10, 2025
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.
FDA Recall
Open, Classified
·CARIS LIFE SCIENCES·Product code PQP·June 17, 2025
Medical Technology Promedt Consulting GmbH
Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices
ALARIS SECONDARY SET
FDA Adverse Event
Injury
·CAREFUSION·Product code FPA·September 10, 2018
Quantum Medical Ltd.
Importer
🇧🇬 Bulgaria·3 Manufacturers
MPS Medical Product Service GmbH
Authorized representative
🇩🇪 Germany·35 Manufacturers·1959 Devices
AF Pharma Service Europe SL
Authorized representative
🇪🇸 Spain·51 Manufacturers·881 Devices
Everbiz GmbH
Authorized representative
🇩🇪 Germany·44 Manufacturers·110 Devices
QbD RepS BV
Authorized representative
🇧🇪 Belgium·86 Manufacturers·1555 Devices
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Wellkang Ltd
Authorized representative
259 Manufacturers·3500 Devices
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Umedwings Netherlands B.V.
Authorized representative
🇳🇱 Netherlands·90 Manufacturers·8432 Devices
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
Obelis s.a.
Authorized representative
🇧🇪 Belgium·546 Manufacturers·18515 Devices