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ISO 13485:2016
Medical Devices Quality
Management System
CE IVDD
CE RoHS
CE EMC
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R&D Center approval
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Baby Unicorn 200
GMP Certification
QuantumPACK™ EASY RSV Ag MFDS Manufacturing approval (Class 3)
NanoPACK™ COVID-19 Ag Home MFDS Manufacturing approval (Class 3)
QuantumPACK™ EASY COVID-19 Ag MFDS Manufacturing approval (Class 3)
NanoPACK™ COVID-19 Ag MFDS Manufacturing approval (Class 3)
QuantumPACK™ EASY Influenza A+B MFDS Manufacturing approval (Class 3)
Medical Immunofluorescence Measurement Device Manufacturing Declaration (QDITS™ Mini)
Medical Immunofluorescence Measurement Device Manufacturing Declaration (QDITS™ Basic)
QuantumPACK™ Improvement Patent (CN113614201)
QuantumPACK™ Improvement Patent (US11,884,852)
QuantumPACK™ Improvement Patent (US11,851,592)
QuantumPACK™ Improvement Patent (JP7353666)
QuantumPACK™ Improvement Patent (CN111183202)
QuantumPACK™ Improvement Patent (EP3666850, BE, DK, FR, GB, DE, IT, ES, SE, CH)
QuantumPACK™ Improvement Patent (JP7162150)
QuantumPACK™ Improvement Patent (JP7058401)
QuantumPACK™ Improvement Patent (KR102306937)
QuantumPACK™ Improvement Patent (KR102430149)
QuantumPACK™ Improvement Patent (KR102012716)
QuantumPACK™ Improvement Patent (KR101960616)
Patent exclusive license (KR1651798, QuantumPACK™)
Patent exclusive license (KR1609618, QuantumPACK™)