- 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
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
24.09.2026 16:47
Sync status
Successful
Device
3609590
Actor
47882
Certificate
3409
TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor & Micro
- 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
- 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
TRUPCR® BCR-ABL1 Minor Quantitative Kit
- 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
TRUPCR® MTHFR Mutation Detection Kit
- 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
TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit
- 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
TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit
- 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
TRUPCR® HLA B-27 Real-Time PCR Kit
- 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
HEMOPHILIA B Yeni Nesil Dizi Analizi ile F9 Mutasyonlarını Saptama Kiti
- 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
FAST-HBB NGS Sequencing Kit
- 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
Yeni Nesil Dizi Analizi ile CFTR Mutasyonlarını Saptama Kiti
- 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
gb GENETIC HFE
- 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
SPOT-it TREC & SMN1 Screening Kit
- 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
DEV-5 Dye Set, MultiCap
- 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
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05744003510313
- Basic UDI-DI
- 574400351MFG03011085
- Reference
- MFG030112
- EMDN
- W0106010306
- EMDN description
- MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
- First on market country
- -
- Safety summary (SSCP/SSP)
- BGIEU-STP-CE-116-011 · Rev. 3
- Authorised representative
- -
- Last updated
- 02.07.2026 22:44
160 tests/kit
- Manufacturer
- CapitalBio Genomics Co.,Ltd.
- Manufacturer SRN
- CN-MF-000027716
- UDI-DI
- 06974776970000
- Basic UDI-DI
- 697477697FAL01RS
- Reference
- 160 tests/kit
- EMDN
- W0106010399
- EMDN description
- CHROMOSOMAL DISORDERS TESTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 02.07.2026 17:27
Vanadis Core Reagent Cartridge II
- Manufacturer
- Wallac Oy
- Manufacturer SRN
- FI-MF-000022620
- UDI-DI
- 06438147382507
- Basic UDI-DI
- 6438147Vanadis_RC2XU
- Reference
- 3222-002B
- EMDN
- W0106010399
- EMDN description
- CHROMOSOMAL DISORDERS TESTS - OTHER
- First on market country
- Finland
- Authorised representative
- -
- Last updated
- 02.07.2026 09:04
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05744003510245
- Basic UDI-DI
- 574400351MFG03011085
- Reference
- MFG030110
- EMDN
- W0106010306
- EMDN description
- MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
- First on market country
- -
- Safety summary (SSCP/SSP)
- BGIEU-STP-CE-116-011 · Rev. 3
- Authorised representative
- -
- Last updated
- 02.07.2026 06:32
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05744003510252
- Basic UDI-DI
- 574400351MFG03011085
- Reference
- MFG030110
- EMDN
- W0106010306
- EMDN description
- MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
- First on market country
- -
- Safety summary (SSCP/SSP)
- BGIEU-STP-CE-116-011 · Rev. 3
- Authorised representative
- -
- Last updated
- 02.07.2026 06:32
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05744003510269
- Basic UDI-DI
- 574400351MFG03011085
- Reference
- MFG030111
- EMDN
- W0106010306
- EMDN description
- MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
- First on market country
- -
- Safety summary (SSCP/SSP)
- BGIEU-STP-CE-116-011 · Rev. 3
- Authorised representative
- -
- Last updated
- 02.07.2026 06:32