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SB-KAWASUMI LABORATORIES, INC.

Japan·JP-MF-000011253

Last updated September 17, 2026

Information

Country: Japan
Address: 3-25-4, Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
Website: sb-kawasumi.jp
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +81-44-589-8070
PRRC Contact: Katsu Furuya
EUDAMED SRN: JP-MF-000011253
FDA FEI Number: 1000163068
DUNS Number: —

Catalogue (452)

Page 2 of 10

Device	Model / Reference	Registries	Class	Status
A. V. Fistula Sets GF-1328EMG	GF-1328EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-2227EMG	GR-2227EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-1335E	GR-1335E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-5317EMG	GR-5317EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-2217E/1317E	GF-2217E/1317E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-5327E	GR-5327E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-1308E	GR-1308E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-5304EMG	GR-5304EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-6115E	GR-6115E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-6218EMG	GR-6218EMG	EUDAMED	Class IIa	Active
Arterial Venous Fistula Set	GR-6214EMG	EUDAMED	Class IIa	Active
Arterial Venous Fistula Set KAWASUMI PAINLESS NEEDLE	GF-6586E	EUDAMED	Class IIa	Active
Arterial Venous Fistula Set	GF-6217E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-2228E	GR-2228E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-6207EMG	GR-6207EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-5585E	GF-5585E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-1318EMG	GR-1318EMG	EUDAMED	Class IIa	Active
Arterial Venous Fistula Set	GR-6218E	EUDAMED	Class IIa	Active
Plasma Separator- Evaclio Evaclio EC-4C20	Evaclio EC-4C20	EUDAMED	Class IIb	Active
A. V. Fistula Sets GR-2226EMG	GR-2226EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-6588E	GR-6588E	EUDAMED	Class IIa	Active
Arterial Venous Fistula Set	GR-5314E	EUDAMED	Class IIa	Active
Plasma Component Separator- Cascadeflo EC EC-30W	EC-30W	EUDAMED	Class IIb	Active
A. V. Fistula Sets GF-6214E/5314E	GF-6214E/5314E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-2208E/1308E	GR-2208E/1308E	EUDAMED	Class IIa	Active
A. V. Fistula Sets for Hemodialysis	AVFE1625CYFG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-1305EMG	GR-1305EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-6205E/5305E	GR-6205E/5305E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-2208EMG	GF-2208EMG	EUDAMED	Class IIa	Active
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing	K252355	FDA 510(k)	Class II	Active
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)	K230408	FDA 510(k)	Class II	Active
SB Knife Jr2 (MD-47702 and MD-47702L)	K241855	FDA 510(k)	Class II	Active
K-SHIELD Zen	K220799	FDA 510(k)	Class II	Active
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)	K223810	FDA 510(k)	Class II	Active
A. V. Fistula Sets GF-6218E	GF-6218E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-2418S0E	GF-2418S0E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-6217EMG	GR-6217EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-1306E	GR-1306E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-2588E	GR-2588E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-2214E	GR-2214E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-5586E	GR-5586E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-2226E/1326E	GF-2226E/1326E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-5315EMG	GR-5315EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-6156E	GF-6156E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-5307EMG	GF-5307EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-2207EMG	GF-2207EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-6118EMG	GF-6118EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-65X6E	GF-65X6E	EUDAMED	Class IIa	Active
A. V. Fistula Sets GR-2236EMG	GR-2236EMG	EUDAMED	Class IIa	Active
A. V. Fistula Sets GF-6204E	GF-6204E	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

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Authorities

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FDA Establishments (1)

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

Sb-Kawasumi Laboratories, Inc. US