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VELA OPERATIONS SINGAPORE PTE. LTD.

Singapore·SG-MF-000025684

Last updated September 17, 2026

What VELA OPERATIONS SINGAPORE PTE. LTD. makes

The company manufactures in vitro diagnostic (IVD) kits and reagents for nucleic acid extraction, sequencing, and amplification, including those for HIV-1 genotyping and SARS-CoV-2 detection. Their portfolio includes semi-automated thermal cyclers for laboratory use, as well as consumables like extraction reagents, sequencing solutions, and PCR instruments. Products are designed for viral nucleic acid isolation, amplification, and sequencing workflows, supporting molecular diagnostics in clinical and research settings.

These devices are regulated under EU IVD Directive classifications (Class A, Class I, Class II, Annex II List A/B) and fall under FDA’s UDI system. The company’s products are listed in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in Singapore.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Singapore
Address: 50 Science Park Road, Singapore, Singapore
Website: www.veladx.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +65 6672 6060
PRRC Contact: Boon King Teh
EUDAMED SRN: SG-MF-000025684
FDA FEI Number: 3009875001
DUNS Number: 595361724

Catalogue (103)

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Device	Model / Reference	Registries	Class	Status
Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)	300755	EUDAMED	IVD General	Active
Sentosa ST401e	400120	EUDAMEDFDA UDI	Class A	Active
Sentosa SA HSV1/2 Quantitation Standards (2x13)	300071	EUDAMED	IVD General	Active
Sentosa SA Salmonella PCR Test (4x8)	300028	EUDAMED	IVD General	Active
RapidKey COVID-19 Antigen Self Test (2)	301112	EUDAMED	IVD General	Active
ViroKey HT Virus Total Nucleic Acid Kit (4x96)	301089	EUDAMED	Class A	Active
Sentosa SX Lysis Plate (96)	300649	EUDAMED	Class A	Active
Sentosa SX Lysis Plate (10x96)	300704	EUDAMED	Class A	Active
Sentosa SA BRAF V600 PCR Test (4x8)	300003	EUDAMED	IVD General	Active
Sentosa SA HSV1/2 Quantitation Controls (4x2)	300072	EUDAMED	IVD General	Active
Sentosa SA EBV Quantitation Controls (4x2)	300110	EUDAMED	IVD General	Active
Sentosa SA VZV PCR Test (4x24)	300081	EUDAMED	IVD General	Active
Sentosa SA CMV Controls Set (8x3)	300624	EUDAMED	IVD Annex II List B	Active
ViroKey SARS-CoV-2 RT-PCR Test	300680	EUDAMED	IVD General	Active
Sentosa SA ZIKV RT-PCR Test	300614	EUDAMED	IVD General	Active
Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)	300753	EUDAMED	IVD General	Active
VELA Analytics	480175	EUDAMED	IVD General	Active
RapidKey COVID-19 Antigen Self Test (5)	301113	EUDAMED	IVD General	Active
Sentosa SA CMV Quantitation Controls (4x2)	300059	EUDAMED	IVD Annex II List B	Active
Great Basin Bordetella Direct Test	300782	EUDAMED	IVD General	Active
Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)	300154	EUDAMED	Class A	Active
Sentosa SQ Melanoma Panel (4x8)	690008	EUDAMED	IVD General	Active
Sentosa SQ HIV Genotyping Assay (4x16)	690037	EUDAMED	IVD Annex II List A	Active
Sentosa SA VZV PCR Test (4x48)	300675	EUDAMED	IVD General	Active
Sentosa SA HHV6 Quantitative PCR Test	300157, 300184, 300180, 300673	EUDAMED	IVD General	Active
Sentosa SA BKV PCR Test (4X48)	300636	EUDAMED	IVD General	Active
Sentosa SA VZV Controls (8x3)	300690	EUDAMED	IVD General	Active
Sentosa SA RSV RT-PCR Test	111326	EUDAMED	IVD General	Active
Sentosa SA Dengue I-IV RT-PCR Test (4x8)	300050	EUDAMED	IVD General	Active
Sentosa SA HHV6 Controls Set (8x3)	300688	EUDAMED	IVD General	Active
Sentosa SA HSV1/2 PCR Test (4x24)	300064	EUDAMED	IVD General	Active
Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16)	300351	EUDAMED	Class A	Active
Sentosa SA Rotavirus RT-PCR Test (4x24)	300192	EUDAMED	IVD General	Active
Sentosa SA BKV Quantitation Controls (4x2)	300092	EUDAMED	IVD General	Active
ViroKey MP HPV 16, 18 PCR Test	301119, 301120, 301121	EUDAMED	IVD General	Active
Sentosa SA EBV Quantitation Standards (2x13)	300109	EUDAMED	IVD General	Active
Great Basin Group B Streptococcus Test	300781	EUDAMED	IVD General	Active
Sentosa ST401i	400124	EUDAMEDFDA UDI	Class A	Active
Sentosa SA EBV PCR Test (4X48)	300627	EUDAMED	IVD General	Active
Sentosa SA KRAS PCR Test (4x8)	300083	EUDAMED	IVD General	Active
ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48)	301069	EUDAMED	IVD General	Active
Sentosa SA Direct MRSA/SA PCR Test (4x24)	300247	EUDAMED	IVD General	Active
Sentosa SQ Thyroid Cancer Panel (4x8)	690034	EUDAMED	IVD General	Active
Sentosa SQ NSCLC Panel (4x8)	690010	EUDAMED	IVD General	Active
Sentosa SA CMV Quantitative PCR Test (4x24)	300114	EUDAMED	IVD Annex II List B	Active
Sentosa SA HSV1/2 Controls Set (8x3)	300686	EUDAMED	IVD General	Active
Sentosa SQ Reporter Software	480169, 480183, 480185, 480187, 480204	EUDAMED	IVD General	Active
Sentosa SA BKV Quantitation Standards (2x13)	300091	EUDAMED	IVD General	Active
Sentosa SA CHIKV RT-PCR Test (4x8)	300048	EUDAMED	IVD General	Active
Sentosa SA BKV PCR Test (4x24)	300088	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Vela Diagnostics Germany GmbH DE

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