SysCan BioTech (Suzhou) Co., Ltd
China CN-MF-000040462 Last updated 8 Jun 2026
- Devices
- 60
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
D-Dimer Assay Kit Ref Ci-DD-24
Thrombin Time (TT) Reagent Ref CP-TT-1000
Prothrombin Time (PT) Reagent Ref CP-PT-1000
Thrombin Reagent (for Fbg assay) Ref Ci-TFIB-04
Thrombin Reagent (for Fbg assay) Ref CP-TFIB-1000
Fibrin Degradation Product (FDP) Assay Kit Ref CP-FDP-1000
D-Dimer Assay Kit Ref Ci-DD-12
活化部分凝血活酶时间检测试剂盒(鞣花酸凝固法) Ref Ci-APTT-10E
Antithrombin III Assay Kit Ref CP-AT-1000
Fibrinogen Reference Plasma Ref STD-FIB-01
D-Dimer Control Ref DDII-01
D-Dimer Control Ref ATIII-01
D-Dimer Assay Kit Ref Ci-DD-24
Coagulation Control Plasma Ref CONP-II-01
D-Dimer Control Ref DDI-01
Thrombin Reagent (for Fbg assay) Ref Ci-TFIB-04
Fibrinogen Reference Plasma Ref STD-FIB-01
D-Dimer Control Ref DDII-01
Coagulation Control Plasma Ref CONP-II-01
D-Dimer Assay Kit Ref Ci-DD-12
Fibrin Degradation Product (FDP) Control Ref FDPII-01
Prothrombin Time (PT) Reagent Ref Ci-PT-04
Activated Partial Thromboplastin Time (APTT) Reagent(Ellagic Acid) Ref CP-APTT-1000E
D-Dimer Assay Kit Ref CP-DD-1000
Fibrin Degradation Product (FDP) Control Ref FDPI-01
Coagulation Control Plasma Ref CONP-I-01
Antithrombin III Control Ref ATIII-02
Thrombin Time (TT) Reagent Ref Ci-PT-05
Thrombin Time (TT) Reagent Ref Ci-TT-05
Antithrombin III Assay Kit Ref Ci-AT-24
Fibrin Degradation Product (FDP) Assay Kit Ref Ci-FDP-10
Thrombin Reagent (for Fbg assay) Ref Ci-TFIB-02
Antithrombin III Assay Kit Ref Ci-AT-12
Antithrombin III Control Ref ATIII-01
Clean Solution Ref Ci-C-50
Clean Solution Ref ACL-CB-80
Imidazole Buffered Saline Ref CM-IBS-15
Rinse Solution Ref CM-W-CON-2000
Clean Solution Ref CS-C-500
Rinse Solution Ref Ci-W-2000
Clean Solution Ref ACL-CA-500
Clean Solution Ref CN-C-2000
Clean Solution Ref RT-C-50
Rinse Solution Ref TOP-W-4000
Rinse Solution Ref STA-W-2500
Clean Solution Ref Ci-C-15
Clean Solution Ref RT-C-30
Showing 1-50 of 60
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Authorised representatives
- Obelis s.a. BE
What SysCan BioTech (Suzhou) Co., Ltd makes
SysCan BioTech (Suzhou) Co., Ltd manufactures sterile cleaning and rinsing solutions for medical device preparation and sterilization processes. These include buffered saline formulations, such as imidazole-buffered saline, alongside various clean and rinse solutions designed for pre-procedure preparation.
The company’s portfolio is classified under EU Medical Device Regulation (MDR) as Class A devices and is registered in the EU’s eudamed database. The manufacturer is based in China.
Frequently asked questions
What types of medical devices does SysCan BioTech (Suzhou) Co., Ltd manufacture?
SysCan BioTech (Suzhou) Co., Ltd specializes in sterile cleaning and rinsing solutions used in medical device preparation and sterilization. Their portfolio includes buffered saline formulations like imidazole-buffered saline, as well as clean and rinse solutions designed for pre-procedure cleaning of medical devices.
Where is SysCan BioTech (Suzhou) Co., Ltd based?
The company is headquartered in Suzhou, China. This location reflects its operational base for manufacturing and distributing its medical device-related solutions.
Which regulatory registries list SysCan BioTech’s devices?
SysCan BioTech’s devices are listed in the eudamed database, which is the official EU registry for medical devices under the EU Medical Device Regulation (MDR). This registration ensures traceability and compliance tracking for their products within the European market.
How are SysCan BioTech’s devices classified under EU regulations?
Under the EU Medical Device Regulation (MDR), SysCan BioTech’s products—such as cleaning and rinsing solutions—are classified as Class A devices. This classification applies to low-risk medical devices, including those used for preparation and sterilization processes, where the risk to patient safety is minimal.
Information
- Country
- China
- Address
- North 4th Floor, Building 19, No.8 JinFeng Road,, Suzhou, China
- Website
- syscanbio.com
- [email protected]
- PRRC contact
- linglin zheng
- EUDAMED SRN
- CN-MF-000040462