Sysmex Corporation
Active in EUDAMEDJapanfrom SRN EUDAMED FDA SRN JP-MF-000014037 FEI 3010421384
Sysmex Corporation is a medical device manufacturer based in Japan, with 305 devices listed in EUDAMED and FDA GUDID (EU Class A and IVD General; FDA Class II and I) as of 13 Nov 2026.
- Devices
- 305
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 227
- FDA GUDID 130
- Device classes
- EU Class A 161
- FDA Class II 53
- FDA Class I 44
- EU IVD General 43
- EU Class C 4
- Top EMDN categories
- Sites and related companies
- Sysmex Europe SE authorised representative
- Identifiers
- EUDAMED SRN JP-MF-000014037
- FDA FEI 3010421384
- DUNS 690664461
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- Sysmex Europe SEDE
What Sysmex Corporation makes
Sysmex Corporation manufactures automated hematology analyzers, including systems like the CS-2500 and HISCL Cuvette L, which measure blood cell counts and morphology. Their portfolio also includes flow cytometry devices such as the Fluorocell WET and TS-10 for immunophenotyping and cell analysis. Additional products include cuvettes (e.g., SB Cuvette II, CV-65) for sample preparation, sheath fluids (e.g., UF-CELLSHEATH) for flow cytometry, and coagulation analyzers like the CA-660 and CA-650. The company also produces reagents (e.g., ST-41, PU-17) for blood testing and cell staining, as well as a sample preparation system (SA-01).
These devices are classified under EUDAMED as Class A, Class C, and In Vitro Diagnostic (IVD) General category instruments. The company’s products are registered in the European Database on Medical Devices (eudamed). Sysmex Corporation is based in Japan.
Catalogue
Search and filter all 305 devicesShowing 1-50 of 305
Company details
- EUDAMED SRN
- JP-MF-000014037
- FDA FEI number
- 3010421384
- DUNS number
- 690664461
- EUDAMED status
- Active
- EUDAMED registered name
- SYSMEX CORPORATION
- EUDAMED abbreviated name
- SCORP
- Registered address
- 4-4-4 Takatsukadai, Nishi-ku, 651-2271, Kobe, Japan
- Phone
- +1(888)879-7644
- PRRC contact
- Yasumasa Akai
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 3 Jun 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- V13 110368 0003 Active
Quality management system EU IVDR
- Issued
- 3 Jul 2026
- Expires
- 3 Jun 2031
- Reason
- Add device or group
FDA establishments
- Sysmex Corp. US
Frequently asked questions
How many devices does SYSMEX CORPORATION have in the registry?
The registry currently lists 305 devices for SYSMEX CORPORATION. Devices recorded under merged duplicate company entries are counted once.
Which registries list SYSMEX CORPORATION's devices?
Among its 50 most recently registered devices, SYSMEX CORPORATION has devices listed in EUDAMED (42 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SYSMEX CORPORATION's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SYSMEX CORPORATION's devices are Class I, Class II, IVDR Class A, IVDR Class C and IVD general. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for SYSMEX CORPORATION?
EUDAMED lists 1 certificate for SYSMEX CORPORATION (quality management system) under IVDR. The most recent was issued on 3 Jul 2026.
What are the newest devices from SYSMEX CORPORATION in the registry?
The most recently registered devices listed for SYSMEX CORPORATION include Automated Hematology Analyzer XP series, XP-300, BT-40 Transportation Unit, Urine Sample Transportation Unit ST-12 and HISCL HIT IgG Control.
Which FDA establishments are linked to SYSMEX CORPORATION?
1 FDA establishment is linked to SYSMEX CORPORATION in the registry; they are listed on the company page.