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KITAZATO CORPORATION

Japan·JP-MF-000018374

Last updated September 17, 2026

Information

Country: Japan
Address: 100-10, Yanagishima, Fuji, Japan
Website: www.kitazato.co.jp
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +81 545 65 7122
PRRC Contact: Kyoko Izumi
EUDAMED SRN: JP-MF-000018374
FDA FEI Number: 3008876063
DUNS Number: —

Catalogue (113)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Plasticware	83002	EUDAMEDFDA UDI	Class IIa	Active
Hypure® Oil	96011	EUDAMEDFDA UDI	Class IIa	Active
Hypure® Oil	96014	EUDAMEDFDA UDI	Class IIa	Active
ET Catheter	234322	EUDAMED	Class I	Active
ET Catheter	225723	EUDAMED	Class I	Active
Hypure® Oil	96001	EUDAMEDFDA UDI	Class IIa	Active
ET Catheter	223340	EUDAMEDFDA UDI	Class I	Active
Plasticware	83022	EUDAMED	Class IIa	Active
Plasticware	83007	EUDAMEDFDA UDI	Class IIa	Active
Hypure® Oil	96015	EUDAMEDFDA UDI	Class IIa	Active
ET Catheter	243020	EUDAMED	Class I	Active
Plasticware	83010	EUDAMEDFDA UDI	Class IIa	Active
Plasticware	83020	EUDAMEDFDA UDI	Class IIa	Active
ET Catheter	223322	EUDAMED	Class I	Active
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA	K193522	FDA 510(k)	Class II	Active
Ultra-Fast Vitri; Ultra-Fast Warm	K251305	FDA 510(k)	Class II	Active
Cryotop®US-flash and Cryotop®US-scoop	K181469	FDA 510(k)	Class II	Active
Cumulus Remover	K182002	FDA 510(k)	Class II	Active
Sperm Freeze, Sperm Fridge	K192845	FDA 510(k)	Class II	Active
Ultra-Fast Warm	K260248	FDA 510(k)	Class II	Active
Vitrification Kit and Thawing Kit	K171748	FDA 510(k)	Class II	Active
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])	K200249	FDA 510(k)	Class II	Active
SepaSperm Washing Solution, SepaSperm Solution	K190199	FDA 510(k)	Class II	Active
ET Catheter	215023	EUDAMED	Class I	Active
Kitazato OPU Needle	327350	EUDAMEDFDA UDI	Class IIa	Active
Kitazato OPU Needle	339350	EUDAMED	Class IIa	Active
Kitazato OPU Needle	268004	EUDAMED	Class IIa	Active
ET Catheter	205123	EUDAMED	Class I	Active
ET Catheter	225518	EUDAMED	Class I	Active
Plasticware	83017	EUDAMEDFDA UDI	Class IIa	Active
ET Catheter	225423	EUDAMED	Class I	Active
ET Catheter	233322	EUDAMED	Class I	Active
Kitazato OPU Needle	397352	EUDAMED	Class IIa	Active
Cryotop®	81229	EUDAMED	Class IIa	Active
Kitazato OPU Needle	359352	EUDAMED	Class IIa	Active
Cryotop®	81204	EUDAMED	Class IIa	Active
ET Catheter	224425	EUDAMED	Class I	Active
Holding pipettes (MT-HD)	95303	EUDAMEDFDA UDI	Class IIa	Active
Hypure® Oil	96010	EUDAMEDFDA UDI	Class IIa	Active
Hypure® Oil	96012	EUDAMEDFDA UDI	Class IIa	Active
ET Catheter	215123	EUDAMED	Class I	Active
Hypure® Oil	96002	EUDAMEDFDA UDI	Class IIa	Active
ET Catheter	224422	EUDAMED	Class I	Active
Kitazato OPU Needle	317001	EUDAMED	Class IIa	Active
ET Catheter	244020	EUDAMED	Class I	Active
ET Catheter	294115	EUDAMED	Class I	Active
Holding pipettes (MT-HD)	95361	EUDAMEDFDA UDI	Class IIa	Active
Plasticware	83002	EUDAMED	Class IIa	Active
Cryotop®	81125	EUDAMEDFDA UDI	Class IIa	Active
Holding Pipette (MT-HD)	95300	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Biomedical Supply, S.l. ES

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Kitazato Corporation US