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Morgan HLA SSP DQB Typing Kit

33290

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: TBG Biotechnology Corp.
Manufacturer SRN: TW-MF-000029664
UDI-DI: 04718050360062
Basic UDI-DI: B-04718050360062
Reference: 33290
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Greece
Authorised representative: mdi Europa GmbH
Last updated: 02.08.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

gb GENETIC FRUCTO

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925220
Basic UDI-DI: 85952239000004X2
Reference: 3252-050
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 18:33

Manufacturer products View details

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173657006
Basic UDI-DI: B-00810173657006
Reference: N7001D
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656993
Basic UDI-DI: B-00810173656993
Reference: N7001C
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

FetoGnost® Kit RHD

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Ingenetix GmbH
Manufacturer SRN: AT-MF-000001501
UDI-DI: 09120110505897
Basic UDI-DI: 912011050HUFGRXX8D
Reference: HUFG100
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Austria
Safety summary (SSCP/SSP): FB257_V04 · Rev. 3.0
Authorised representative: -
Last updated: 01.08.2026 00:39

Manufacturer products Open in EUDAMED View details

gb PHARM CYP2C19

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925428
Basic UDI-DI: 85952239000016X9
Reference: 3254-050
EMDN: W0106030104
EMDN description: CYP2C19
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:17

Manufacturer products View details

gb GENETIC A1AT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925114
Basic UDI-DI: 85952239000001WU
Reference: 3251-025
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:17

Manufacturer products View details

gb GENETIC LACTO

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223921918
Basic UDI-DI: 85952239000007X8
Reference: 3219-025
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:17

Manufacturer products View details

Universal Sequencing Reaction Kit T1+ App-D FCL SE50

Universal Sequencing Reaction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270291
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002768-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974996850366

Cell-free DNA Library Preparation Kit

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingKitProfessional testingReagent

Manufacturer: Cygnus Biosciences (Beijing) Co., Ltd.
Manufacturer SRN: CN-MF-000027934
UDI-DI: 06974996850366
Basic UDI-DI: 697499685005TX
Reference: G-211-185-101
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T7 HM FCL PE100

Universal Sequencing Reaction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318130848
Basic UDI-DI: 697431813S-KitMW
Reference: 940-000250-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

AmoyDx® AutoExtract Kit (Whole Blood DNA)

48 tests/kit