Authorized Representative
π³π± Netherlands
Active
R Sight B.V.
SRN: NL-AR-000010445
Β·
Roald Dahllaan 47, 5629 MC Eindhoven, Netherlands
Manufacturers
14
Devices
111
Certificates
2
PRRCs
1
Basic Information
- Address
- Roald Dahllaan 47, 5629 MC Eindhoven, Netherlands
- [email protected]
- VAT Number
- NL860761824B01
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. | π¨π³ China | CN-MF-000005925 |
| CHISON Medical Technologies Co., Ltd. | π¨π³ China | CN-MF-000021605 |
| Shenzhen Dartmon Biotechnology Co., Ltd. | π¨π³ China | CN-MF-000019183 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | π¨π³ China | CN-MF-000031446 |
| Jiangsu Yveelt Medical Equipment Co., Ltd. | π¨π³ China | CN-MF-000035505 |
| Changshu Pingfang Wheelchair Co., Ltd. | π¨π³ China | CN-MF-000035424 |
| Shanghai Runpu Biotechnology Co.,Ltd. | π¨π³ China | CN-MF-000027207 |
| MABSKY BIO-TECH CO., LTD. | π¨π³ China | CN-MF-000038680 |
| Suzhou Betrue Technology Co., Ltd. | π¨π³ China | CN-MF-000039348 |
| Huachenyang (Shenzhen) Technology Co., Ltd. | π¨π³ China | CN-MF-000020236 |
| Kunshan Yiyuan Medical Technology Co.,Ltd | π¨π³ China | CN-MF-000043033 |
| Shenzhen UpnMed Equipment co.,ltd | π¨π³ China | CN-MF-000019212 |
| Jiangsu Medomics Medical Technology Co.,Ltd. | π¨π³ China | CN-MF-000030226 |
| HEPHO MEDICAL CO., LTD. | π¨π³ China | CN-MF-000035171 |
Manufacturers
Jiangsu Yveelt Medical Equipment Co., Ltd.
Manufacturer
π¨π³ China
CHISON Medical Technologies Co., Ltd.
Manufacturer
π¨π³ China·4 Basic UDI-DIs·14 Devices·2 Importers
HEPHO MEDICAL CO., LTD.
Manufacturer
π¨π³ China
Shenzhen UpnMed Equipment co.,ltd
Manufacturer
π¨π³ China·4 Basic UDI-DIs·7 Devices·1 Importer·TΓV Rheinland LGA Products GmbH
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer
π¨π³ China·61 Basic UDI-DIs·69 Devices·2 Importers
Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer
π¨π³ China·1 Basic UDI-DI·4 Devices·2 Importers·Sertio Oy
Shenzhen Dartmon Biotechnology Co., Ltd.
Manufacturer
π¨π³ China
Huachenyang (Shenzhen) Technology Co., Ltd.
Manufacturer
π¨π³ China·2 Basic UDI-DIs·2 Devices
Suzhou Betrue Technology Co., Ltd.
Manufacturer
π¨π³ China·1 Basic UDI-DI·2 Devices
Changshu Pingfang Wheelchair Co., Ltd.
Manufacturer
π¨π³ China·1 Basic UDI-DI·3 Devices
Kunshan Yiyuan Medical Technology Co.,Ltd
Manufacturer
π¨π³ China
Changsha Easyinsmile Intelligence Technology Co., Ltd.
Manufacturer
π¨π³ China·7 Basic UDI-DIs·7 Devices
Shanghai Runpu Biotechnology Co.,Ltd.
Manufacturer
π¨π³ China·1 Basic UDI-DI·1 Device
MABSKY BIO-TECH CO., LTD.
Manufacturer
π¨π³ China·1 Basic UDI-DI·2 Devices
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | HD601444330001 | Shenzhen UpnMed Equipment co.,ltd | TΓV Rheinland LGA Products GmbH | Expired |
| IVDR Technical Documentation | EU-TDA-FI-06912-800035-2025-1 | Jiangsu Medomics Medical Technology Co.,Ltd. | Sertio Oy |
Devices
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
SonoEye G5
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
SonoEye G2
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·1 country
CHISON
Device
EU MDR
·
Eu Md Class 2a
·CHISON Medical Technologies Co., Ltd.·On the market·2 countries
UpnMed
Device
EU MDR
·
Eu Md Class 1
·Shenzhen UpnMed Equipment co.,ltd·On the market·32 countries
UpnMed
Device
EU MDR
·
Eu Md Class 2b
·Shenzhen UpnMed Equipment co.,ltd·On the market·1 country
UpnMed
Device
EU MDR
·
Eu Md Class 2b
·Shenzhen UpnMed Equipment co.,ltd·On the market·1 country
UpnMed
Device
EU MDR
·
Eu Md Class 2b
·Shenzhen UpnMed Equipment co.,ltd·On the market·1 country
UpnMed
Device
EU MDR
·
Eu Md Class 2b
·Shenzhen UpnMed Equipment co.,ltd·On the market·1 country
UpnMed
Device
EU MDR
·
Eu Md Class 1
·Shenzhen UpnMed Equipment co.,ltd·On the market·32 countries
Upnmed
Device
EU MDD
·
Eu Md Class 2b
·Shenzhen UpnMed Equipment co.,ltd·On the market·2 countries
Fully Automated Blood Grouping System
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Fully Automated Blood Grouping System
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
IMMUNOCHEMISTRY REAGENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
AutoMated Nucleic Acid Extraction System
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
AutoMated Nucleic Acid Extraction System
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Fully-automated Haemostasis Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Fully-automated Haemostasis Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Haemostasis Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Haemostasis Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Automated Chemiluminescence Immunoassay Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Automated Chemiluminescence Immunoassay Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
AUTOMATED BLOOD GROUPING ANALYSERS
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
AUTOMATED BLOOD GROUPING ANALYSERS
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Cardiopulmonary Markers Controls
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Cardiac Markers Controls
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
hs-CRP+CRP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
TnI (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
hs-CRP+CRP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
TnI (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
MYO (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
CK-MB (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
MYO (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
CK-MB (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
PCT(CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
PCT(CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
NT-proBNP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
NT-proBNP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
D-Dimer (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
D-Dimer (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
CRP Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
PCT Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Thromboelastography Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Thromboelastography Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Thromboelastography Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Heparin Assay
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Heparin Assay
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Heparin Assay
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Heparin Assay
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Heparin Assay
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Thromboelastography Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Rapid Kaolin Reagent
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Rapid Kaolin Reagent
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Rapid Kaolin Reagent
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Rapid Kaolin Reagent
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Functional Fibrinogen Assay
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Functional Fibrinogen Assay
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Functional Fibrinogen Assay
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
SAA (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
SAA (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
sST2 (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
sST2 (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Lp-PLA2 (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Lp-PLA2 (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
H-FABP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
H-FABP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
FDP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
FDP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Anti-CCP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Anti-CCP (CLIA)
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Anti-CCP Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
SAA Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
sST2 Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
H-FABP Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
Lp-PLA2 Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
FDP Control
Device
EU IVDD
·
Eu Ivd General
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
IMMUNOCHEMISTRY REAGENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
IMMUNOCHEMISTRY REAGENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.·On the market
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Device
EU IVDR
·
Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Device
EU IVDR
·
Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Device
EU IVDR
·
Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Device
EU IVDR
·
Eu Ivd Class D
·Jiangsu Medomics Medical Technology Co.,Ltd.·On the market·12 countries
iClean
Device
EU IVDR
·
Eu Ivd Class A
·Huachenyang (Shenzhen) Technology Co., Ltd.·On the market·32 countries
iClean
Device
EU IVDR
·
Eu Ivd Class A
·Huachenyang (Shenzhen) Technology Co., Ltd.·On the market
VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·Suzhou Betrue Technology Co., Ltd.·Not intended for eu market
VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·Suzhou Betrue Technology Co., Ltd.·Not intended for eu market
ELECTRIC WHEELCHAIR
Device
EU MDR
·
Eu Md Class 1
·Changshu Pingfang Wheelchair Co., Ltd.·On the market·2 countries
DRY THERMAL PRINTER X-RAY FILMS
Device
EU MDR
·
Eu Md Class 1
·Changshu Pingfang Wheelchair Co., Ltd.·On the market
DRY THERMAL PRINTER X-RAY FILMS
Device
EU MDR
·
Eu Md Class 1
·Changshu Pingfang Wheelchair Co., Ltd.·On the market·1 country
Easyinsmile
Device
EU MDR
·
Eu Md Class 1
·Changsha Easyinsmile Intelligence Technology Co., Ltd.·On the market
Easyinsmile
Device
EU MDR
·
Eu Md Class 1
·Changsha Easyinsmile Intelligence Technology Co., Ltd.·On the market
Easyinsmile
Device
EU MDR
·
Eu Md Class 1
·Changsha Easyinsmile Intelligence Technology Co., Ltd.·On the market
Easyinsmile
Device
EU MDR
·
Eu Md Class 1
·Changsha Easyinsmile Intelligence Technology Co., Ltd.·On the market
Easyinsmile
Device
EU MDR
·
Eu Md Class 1
·Changsha Easyinsmile Intelligence Technology Co., Ltd.·On the market
Easyinsmile
Device
EU MDR
·
Eu Md Class 1
·Changsha Easyinsmile Intelligence Technology Co., Ltd.·On the market
Easyinsmile
Device
EU MDR
·
Eu Md Class 1
·Changsha Easyinsmile Intelligence Technology Co., Ltd.·On the market
BT Liss
Device
EU IVDR
·
Eu Ivd Class A
·Shanghai Runpu Biotechnology Co.,Ltd.·On the market
ENZYMES - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·MABSKY BIO-TECH CO., LTD.·On the market·2 countries
CLINICAL CHEMISTRY REAGENTS - OTHER
Device
EU IVDR
·
Eu Ivd Class A
·MABSKY BIO-TECH CO., LTD.·On the market·2 countries