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HT111

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Silver Lake Research Corporation
Manufacturer SRN: US-MF-000027373
UDI-DI: 00850031753020
Basic UDI-DI: B-00850031753020
Reference: HT111
EMDN: W0106010109
EMDN description: SICKLE CELL ANEMIA
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

AmplideX mPCR FMR1 Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493049
Basic UDI-DI: B-00850017493049
Reference: A00401
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

AmplideX HTT SNP/Repeat Phasing Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493032
Basic UDI-DI: B-00850017493032
Reference: A00083
EMDN: W0106010107
EMDN description: HUNTINGTON CHOREA
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

AmplideX SMA Plus Kit (100 rxn)

AmplideX SMA Plus Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493025
Basic UDI-DI: B-00850017493025
Reference: A00056
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-00106010104013V8

FMR1 CGG PCR

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-00106010104013V8
Basic UDI-DI: B-00106010104013V8
Reference: 50 Tests/Kit
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 04.07.2026 09:10

Manufacturer products Authorised representative products Authorised representative actors View details

gb GENETIC APOE

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

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223920621
Basic UDI-DI: 85952239000003WY
Reference: 3206-50
EMDN: W0106010203
EMDN description: ATHEROSCLEROSIS
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 22:47

Manufacturer products View details

TRUPCR® MGMT Methylation Detection Kit

3B1339

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304217
Basic UDI-DI: 89080153043B1339LG
Reference: 3B1339
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor & Micro

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304088
Basic UDI-DI: 89080153043B1267LG
Reference: 3B1267
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® IDH1/2 Detection & Differentiation Kit

3B1338

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304033
Basic UDI-DI: 89080153043B1338LE
Reference: 3B1338
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL1 Minor Quantitative Kit

IVD Class CIVDR 2017/746On the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304026
Basic UDI-DI: 89080153043B1291LD
Reference: 3B1291
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MTHFR Mutation Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930542
Basic UDI-DI: 89080153043B1331KY
Reference: 3B1331/C
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930511
Basic UDI-DI: 89080153043B1321KV
Reference: 3B1321/C
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930481
Basic UDI-DI: 89080153043B1301KP
Reference: 3B1301/C
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® HLA B-27 Real-Time PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930450
Basic UDI-DI: 89080153043B247NM
Reference: 3B247/C
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

MULTIGEN

HEMOPHILIA B Yeni Nesil Dizi Analizi ile F9 Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090349EL
Basic UDI-DI: 8681957090349EL
Reference: M-F9-01
EMDN: W0106010117
EMDN description: OTHER HEMOPHILIA MUTATIONS (VWF, F8, F9)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

8681957090072DY

FAST-HBB NGS Sequencing Kit

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

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090072DY
Basic UDI-DI: 8681957090072DY
Reference: M-HBB-01
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:39

Manufacturer products View details

MULTİGEN

Yeni Nesil Dizi Analizi ile CFTR Mutasyonlarını Saptama Kiti

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

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090041DM
Basic UDI-DI: 8681957090041DM
Reference: M-CF-01
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:39

Manufacturer products View details

gb GENETIC HFE

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

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223920812
Basic UDI-DI: 85952239000005X4
Reference: 3208-025
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:57

Manufacturer products View details

37350134361787

SPOT-it TREC & SMN1 Screening Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 37350134361787
Basic UDI-DI: 7350134361789C
Reference: 4-2020-TS
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:12

Manufacturer products View details

DEV-5 Dye Set, MultiCap

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632062
Basic UDI-DI: 7350040638R401RJ
Reference: 8-R401
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details