- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- Manufacturer SRN
- SG-MF-000025684
- UDI-DI
- 08885013953428
- Basic UDI-DI
- B-08885013953428
- Reference
- 300091
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Vela Diagnostics Germany GmbH
- Last updated
- 10.07.2026 17:17
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
20.09.2026 09:16
Sync status
Successful
Device
3108040
Actor
47631
Certificate
3283
IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use
IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- Manufacturer SRN
- SG-MF-000025684
- UDI-DI
- 08885013953411
- Basic UDI-DI
- B-08885013953411
- Reference
- 300088
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- Vela Diagnostics Germany GmbH
- Last updated
- 10.07.2026 17:17
Fluorion
Fluorion BKV QNP 1.0 Real-Time PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
- Manufacturer SRN
- TR-MF-000023054
- UDI-DI
- 08698898740508
- Basic UDI-DI
- B-08698898740508
- Reference
- M0610202
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 09.07.2026 14:59
LyoSens BKV qPCR Kit
LYO97WS96
IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent
- Manufacturer
- Vitrosens Biotechnology Inc.
- Manufacturer SRN
- TR-MF-000026452
- UDI-DI
- 08685115806093
- Basic UDI-DI
- B-08685115806093
- Reference
- LYO97
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- -
- Last updated
- 09.07.2026 06:22
RevoDx BK Virus Quantitative qPCR Kit
RevoDx BK Virus Quantitative qPCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
- Manufacturer SRN
- TR-MF-000047330
- UDI-DI
- 08684387215626
- Basic UDI-DI
- B-08684387215626
- Reference
- IP202517-100
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 09.07.2026 02:05
RevoDx BK Virus Quantitative qPCR Kit
RevoDx BK Virus Quantitative qPCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
- Manufacturer SRN
- TR-MF-000047330
- UDI-DI
- 08684387215619
- Basic UDI-DI
- B-08684387215619
- Reference
- IP202517-25
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 09.07.2026 02:05
RevoDx BK Virus Quantitative qPCR Kit
RevoDx BK Virus Quantitative qPCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
- Manufacturer SRN
- TR-MF-000047330
- UDI-DI
- 08684387214445
- Basic UDI-DI
- B-08684387214445
- Reference
- IP202517-100
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 09.07.2026 02:01
RevoDx BK Virus Quantitative qPCR Kit
RevoDx BK Virus Quantitative qPCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
- Manufacturer SRN
- TR-MF-000047330
- UDI-DI
- 08684387214438
- Basic UDI-DI
- B-08684387214438
- Reference
- IP202517-25
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 09.07.2026 02:01
RevoDx BK Virus qPCR Kit
RevoDx BK Virus qPCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
- Manufacturer SRN
- TR-MF-000047330
- UDI-DI
- 08684387213677
- Basic UDI-DI
- B-08684387213677
- Reference
- IP202332-100
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 09.07.2026 01:59
RevoDx BK Virus qPCR Kit
RevoDx BK Virus qPCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
- Manufacturer SRN
- TR-MF-000047330
- UDI-DI
- 08684387213660
- Basic UDI-DI
- B-08684387213660
- Reference
- IP202332-25
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Türkiye
- Authorised representative
- -
- Last updated
- 09.07.2026 01:59
TaqPath™ Menu | GeneProof™ BK Virus (BKV) PCR Kit
GeneProof BK Virus (BKV) PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- GeneProof a.s.
- Manufacturer SRN
- CZ-MF-000002370
- UDI-DI
- 08595696304379
- Basic UDI-DI
- B-08595696304379
- Reference
- A58430
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Czechia
- Authorised representative
- -
- Last updated
- 08.07.2026 01:59
GeneProof BK Virus (BKV) MC PCR Kit
GeneProof BK Virus (BKV) MC PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- GeneProof a.s.
- Manufacturer SRN
- CZ-MF-000002370
- UDI-DI
- 08595696301187
- Basic UDI-DI
- B-08595696301187
- Reference
- BKV/MC/205
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Czechia
- Authorised representative
- -
- Last updated
- 08.07.2026 01:58
GeneProof BK Virus (BKV) MC PCR Kit
GeneProof BK Virus (BKV) MC PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- GeneProof a.s.
- Manufacturer SRN
- CZ-MF-000002370
- UDI-DI
- 08595696301170
- Basic UDI-DI
- B-08595696301170
- Reference
- BKV/MC/041
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Czechia
- Authorised representative
- -
- Last updated
- 08.07.2026 01:58
Polyomavirus BK (PBK) Real Time PCR Kit
Polyomavirus BK (PBK) Real Time PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
- Manufacturer SRN
- CN-MF-000017861
- UDI-DI
- 06971042229121
- Basic UDI-DI
- B-06971042229121
- Reference
- OD-0102-02-A+B
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- France
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 06.07.2026 12:03
Polyomavirus BK (PBK) Real Time PCR Kit
Polyomavirus BK (PBK) Real Time PCR Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
- Manufacturer SRN
- CN-MF-000017861
- UDI-DI
- 06971042229114
- Basic UDI-DI
- B-06971042229114
- Reference
- OD-0102-02
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- France
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA
- Last updated
- 06.07.2026 12:03
FluoroType® BKV HT VER 1.0
FluoroType® BKV HT VER 1.0
IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Hain Lifescience GmbH
- Manufacturer SRN
- DE-MF-000008606
- UDI-DI
- 04049055003518
- Basic UDI-DI
- 40490550300001001TR
- Reference
- 61596HT
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Germany
- Authorised representative
- -
- Last updated
- 01.07.2026 18:47
GeneProof BK Virus (BKV) PCR Kit
GeneProof BK Virus (BKV) PCR Kit
IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
- Manufacturer
- GeneProof a.s.
- Manufacturer SRN
- CZ-MF-000002370
- UDI-DI
- 08594161959267
- Basic UDI-DI
- 859569630027QM
- Reference
- BKV/GP/100
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Czechia
- Authorised representative
- -
- Last updated
- 30.06.2026 16:56
GeneProof BK Virus (BKV) PCR Kit
GeneProof BK Virus (BKV) PCR Kit
IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent
- Manufacturer
- GeneProof a.s.
- Manufacturer SRN
- CZ-MF-000002370
- UDI-DI
- 08594161959243
- Basic UDI-DI
- 859569630027QM
- Reference
- BKV/GP/025
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- Czechia
- Authorised representative
- -
- Last updated
- 30.06.2026 16:56
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Abbott Molecular Inc.
- Manufacturer SRN
- US-MF-000017776
- UDI-DI
- 00884999050693
- Basic UDI-DI
- 0884999AMN0985YB
- Reference
- 09N85-090
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- -
- Authorised representative
- Abbott GmbH
- Last updated
- 19.06.2026 22:48
IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Abbott Molecular Inc.
- Manufacturer SRN
- US-MF-000017776
- UDI-DI
- 00884999050679
- Basic UDI-DI
- 0884999AMN0985YB
- Reference
- 09N85-080
- EMDN
- W0105040522
- EMDN description
- BK VIRUS - NA REAGENTS
- First on market country
- -
- Authorised representative
- Abbott GmbH
- Last updated
- 19.06.2026 22:48