Beckman Coulter K.K.
Active in EUDAMEDJapanfrom SRN EUDAMED SRN JP-MF-000051926
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
- Regimes: CE IVDR Registry: EUDAMED
- Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- JP-MF-000051926
- EUDAMED status
- Active
- EUDAMED registered name
- Beckman Coulter K.K.
- EUDAMED abbreviated name
- BEC
- Registered address
- 454-32, Higashino, 411-0931, Shizuoka, Japan
- Website
- beckmancoulter.com
- [email protected]
- Phone
- +81-559991133
- PRRC contact
- Nobuyuki Mizuguchi
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 28 Jun 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- IVDR 837922 Active
Quality management system EU IVDR
- Issued
- 29 Jun 2026
- Expires
- 28 Jun 2031
From the company website
Beckman Coulter Diagnostics helps healthcare professionals provide better patient care by delivering the accurate diagnostic information they need.
Frequently asked questions
How many devices does Beckman Coulter K.K. have in the registry?
The registry currently lists 2 devices for Beckman Coulter K.K.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beckman Coulter K.K.'s devices?
Among its 2 most recently registered devices, Beckman Coulter K.K. has devices listed in EUDAMED (2 devices).
What risk classes do Beckman Coulter K.K.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Beckman Coulter K.K.'s devices are IVDR Class A. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Beckman Coulter K.K.?
EUDAMED lists 1 certificate for Beckman Coulter K.K. (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 29 Jun 2026.
What are the newest devices from Beckman Coulter K.K. in the registry?
The most recently registered devices listed for Beckman Coulter K.K. include DxC 6000 AU-10, Chemistry Analyzer DxC 6000 AU and DxC 6000 AU-20, Chemistry Analyzer DxC 6000 AU AR.