Authorized Representative
🇩🇪 Germany
Active
Vela Diagnostics Germany GmbH
SRN: DE-AR-000016088
·
Albert-Einstein-Ring 15, 22761 Hamburg, Germany
Manufacturers
1
Devices
82
Certificates
4
PRRCs
1
Basic Information
- Address
- Albert-Einstein-Ring 15, 22761 Hamburg, Germany
- [email protected]
- Website
- www.veladx.com
- VAT Number
- DE278915517
- Trade Register
- HRB119835
- EORI
- DE596283233837335
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Vela Operations Singapore Pte. Ltd. | 🇸🇬 Singapore | SG-MF-000025684 |
Manufacturers
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 20744998-1 | Vela Operations Singapore Pte. Ltd. | TÜV Rheinland LGA Products GmbH | Expired |
| IVDD Annex IV (excluding sections 4, 6) | HL 2074998-1 | Vela Operations Singapore Pte. Ltd. | TÜV Rheinland LGA Products GmbH | Expired |
| IVDD Annex IV Section 4 | IL 2074998-2 | Vela Operations Singapore Pte. Ltd. | TÜV Rheinland LGA Products GmbH | Expired |
| IVDD Annex IV Section 4 | IL 2074998-1 | Vela Operations Singapore Pte. Ltd. | TÜV Rheinland LGA Products GmbH | Expired |
Devices
Sentosa SQ Reporter Software
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SX101
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa ST401e
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa ST401i
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ 318 Chip Kit (8)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ Sequencing Kit (8)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa ST Template Kit (8)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ301 Sequencer
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SX Whole Blood Kit (4x24)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
ViroKey SX Virus Total Nucleic Acid (4x48)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
ViroKey HT Virus Total Nucleic Acid Kit (4x96)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SX Lysis Plate (10x96)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SX Lysis Plate (96)
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SX Lysis Beads
Device
EU IVDR
·
Eu Ivd Class A
·Vela Operations Singapore Pte. Ltd.·On the market
VELA Analytics
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Great Basin Group B Streptococcus Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Great Basin Stool Bacterial Pathogens Panel
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Great Basin Bordetella Direct Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
ViroKey Flu A/B & RSV RT-PCR Extension Kit
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA EBV Quantitation Standards (2x13)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA ZIKV RT-PCR Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA VZV Quantitation Standards (2x13)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA VZV Quantitation Controls (4x2)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA VZV PCR Test (4x48)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA VZV PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA VZV Controls (8x3)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA vanA/vanB PCR Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA Strep A PCR Test (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA Salmonella PCR Test (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA RSV RT-PCR Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA Rotavirus RT-PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA NRAS PCR Test (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA Norovirus RT-PCR Test v2.0 (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA KRAS PCR Test (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HSV1/2 PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HSV1/2 Controls Set (8x3)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HSV1/2 Quantitation Controls (4x2)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HSV1/2 Quantitation Standards (2x13)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HSV1/2 PCR Test (4x48)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HSV1/2 PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HHV6 Quantitative PCR Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
ViroKey MP HPV 16, 18 PCR Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HHV6 Quantitation Controls (4x2)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA HHV6 Controls Set (8x3)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA EBV Quantitation Controls (4x2)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA EBV PCR Test (4X48)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA EBV PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA EBV Controls Set (8x3)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA Direct MRSA/SA PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA Dengue I-IV RT-PCR Test (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
ViroKey SARS-CoV-2 RT-PCR Test v2.0 (4x96)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
ViroKey SARS-CoV-2 RT-PCR Test
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA CMV Quantitative PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA CMV Quantitation Controls (4x2)
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA CMV Controls Set (8x3)
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA CHIKV RT-PCR Test (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA C. diff PCR Test v2.0 (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BRAF V600 PCR Test (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BKV PCR Test (4X48)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BKV Quantitation Standards (2x13)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BKV Quantitation Controls (4x2)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BKV PCR Test (4x24)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BKV Controls (8x3)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SA BCR-ABL Major Quantitative RT-PCR Test v2.0 (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ Thyroid Cancer Panel (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ Melanoma Panel (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ NSCLC Panel (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ HIV Genotyping Assay (4x16)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ HCV Genotyping Assay Bundle (4x16)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ CRC Panel (4x8)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
RapidKey COVID-19 Antigen Self Test (25)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
RapidKey COVID-19 Antigen Self Test (7)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
RapidKey COVID-19 Antigen Self Test (5)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
RapidKey COVID-19 Antigen Self Test (2)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market
RapidKey COVID-19 Antigen Self Test (1)
Device
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·On the market·1 country