Manufacturer

Vela Operations Singapore Pte

SingaporeLegal entities : Vela Operations Singapore Pte. Ltd.

First countries of placing on the market declared in EUDAMED : Germany

EU representative : Vela Diagnostics Germany GmbH (Germany)

27 categories, 56 models including 56 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Sentosa SX Lysis Beads 300291 Sentosa SX Lysis Plate (10x96) 300649, 3007042 refs Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) 300042 Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16) 300351 Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) 300154 2 others Sentosa SX Whole Blood Kit (4x24) 300252 ViroKey HT Virus Total Nucleic Acid Kit (4x96) 300678, 3010892 refs	A IVDR	EUDAMED record Report an error
Hsv - NA reagents	W0105040311	Sentosa SA HSV1/2 Controls Set (8x3) 30068698/79 Sentosa SA HSV1/2 PCR Test (4x24) 30006498/79 Sentosa SA HSV1/2 PCR Test (4x24) 30023398/79 Sentosa SA HSV1/2 PCR Test (4x48) 30067198/79 Sentosa SA HSV1/2 Quantitation Controls (4x2) 30007298/79 1 other Sentosa SA HSV1/2 Quantitation Standards (2x13) 30007198/79	– 98/79	EUDAMED record Report an error
Bk virus - NA reagents	W0105040522	Sentosa SA BKV Controls (8x3) 30063398/79 Sentosa SA BKV PCR Test (4x24) 30008898/79 Sentosa SA BKV PCR Test (4X48) 30063698/79 Sentosa SA BKV Quantitation Controls (4x2) 30009298/79 Sentosa SA BKV Quantitation Standards (2x13) 30009198/79	– 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	Sentosa SA EBV Controls Set (8x3) 30063198/79 Sentosa SA EBV PCR Test (4x24) 30010698/79 Sentosa SA EBV PCR Test (4X48) 30062798/79 Sentosa SA EBV Quantitation Controls (4x2) 30011098/79 Sentosa SA EBV Quantitation Standards (2x13) 30010998/79	– 98/79	EUDAMED record Report an error
Varicella zoster - NA reagents	W0105040904	Sentosa SA VZV Controls (8x3) 30069098/79 Sentosa SA VZV PCR Test (4x24) 30008198/79 Sentosa SA VZV PCR Test (4x48) 30067598/79 Sentosa SA VZV Quantitation Controls (4x2) 30007798/79 Sentosa SA VZV Quantitation Standards (2x13) 30007898/79	– 98/79	EUDAMED record Report an error
Cmv - NA reagents	W0105040205	Sentosa SA CMV Controls Set (8x3) 30062498/79 Sentosa SA CMV Quantitation Controls (4x2) 30005998/79 Sentosa SA CMV Quantitative PCR Test (4x24) 30011498/79	– 98/79	EUDAMED record Report an error
Hhv-6,7,8 - NA reagents	W0105040524	Sentosa SA HHV6 Controls Set (8x3) 30068898/79 Sentosa SA HHV6 Quantitation Controls (4x2) 30017898/79 Sentosa SA HHV6 Quantitative PCR Test 300157, 300184, 300673, 30018098/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test 11126798/79 Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24) 30014598/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - IVD medical device software	W02050192	Sentosa SQ Reporter Software 480169, 480183, 480185, 480187, 480198, 48020498/79 VELA Analytics 48017598/79	– 98/79	EUDAMED record Report an error
Automated sample transport systems	W02060102	Sentosa SX101 400089	A IVDR	EUDAMED record Report an error
Bacteriology - NA reagents - other	W0105011699	Great Basin Stool Bacterial Pathogens Panel 30078098/79	– 98/79	EUDAMED record Report an error
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Great Basin Bordetella Direct Test 30078298/79	– 98/79	EUDAMED record Report an error
C.difficile by NA reagents	W0105011804	Sentosa SA C. diff PCR Test v2.0 (4x24) 30024998/79	– 98/79	EUDAMED record Report an error
Chikungunya virus - NA reagents	W0105040525	Sentosa SA CHIKV RT-PCR Test (4x8) 30004898/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Sentosa SA Dengue I-IV RT-PCR Test (4x8) 30005098/79	– 98/79	EUDAMED record Report an error
HIV 1 genotyping - NA reagents	W0105030108	Sentosa SQ HIV Genotyping Assay (4x16) 69003798/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	ViroKey Flu A/B & RSV RT-PCR Extension Kit 30107498/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	Sentosa SA Norovirus RT-PCR Test v2.0 (4x24) 30020298/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables	W02050185	Sentosa SQ 318 Chip Kit (8) 6900253 refs	A IVDR	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	ViroKey MP HPV 16, 18 PCR Test 301119, 301120, 30112198/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Sentosa SA RSV RT-PCR Test 11132698/79	– 98/79	EUDAMED record Report an error
Rotavirus - NA reagents	W0105040506	Sentosa SA Rotavirus RT-PCR Test (4x24) 30019298/79	– 98/79	EUDAMED record Report an error
Salmonella detection by NA reagents	W0105011003	Sentosa SA Salmonella PCR Test (4x8) 30002898/79	– 98/79	EUDAMED record Report an error
Staphylococcal detection by NA reagents	W0105011203	Sentosa SA Direct MRSA/SA PCR Test (4x24) 30024798/79	– 98/79	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	Sentosa SA Strep A PCR Test (4x8) 30003298/79	– 98/79	EUDAMED record Report an error
Strep. b detection by NA reagents	W0105011104	Great Basin Group B Streptococcus Test 30078198/79	– 98/79	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	Sentosa SA ZIKV RT-PCR Test 30061498/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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