EUDAMED update: May 26, 2026

GE Healthcare Japan Corporation

JP-MF-000009291

Active35 devices

Address: Asahigaoka 4-chome, 7-127 191-8503 Hino-Shi Tokyo
Role: Manufacturer
Date of registration: Jul 7, 2021
Country: Japan

GE Healthcare Japan Corporation is a medical device manufacturer registered in EUDAMED. The company has 35 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in Hino-Shi Tokyo, Japan. Explore the regulatory profile, devices and certificates on MD Atlas.

About GE Healthcare Japan Corporation

: JP-MF-000009291
Role: Manufacturer
Country: Japan
Organization name: GE Healthcare Japan Corporation
EU VAT number: 4013401002304-0000
Trade register: 13BZ006216
Date of registration: Jul 7, 2021

Contact details for GE Healthcare Japan Corporation

Email: eudamed@gehealthcare.com
Address: 7-127, ASAHIGAOKA 4-CHOME 191-8503 HINO-SHI TOKYO JAPAN

Competent authority

Name: Agence Nationale de Sécurité du Médicament et des Produits de Santé

Phone: + 33 (1) 5587 3000
Email: contact.eudamed@ansm.sante.fr

Officers and regulatory representatives of GE Healthcare Japan Corporation

HIROSHI Usui
a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
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TOMOHIRO Ito
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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Product	Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
11L-D	11L-D	`5176269`	`00840682110372`	1	On the market
12L-RS	12L-RS	`H40402LY`	`00840682106870`	1	On the market
4Vc-D	4Vc-D	`H40482LS`	`00840682123860`	1	On the market
6Sc-D	6Sc-D	`H46462LS`	`00195278723963`	1	On the market
8C-RS	8C-RS	`H40402LS`	`00840682106962`	1	On the market
9L-D	9L-D	`H40442LM`	`00840682110334`	1	On the market
9L-RS	9L-RS	`H40442LL`	`00840682110006`	1	On the market
ASiR-V	ASiR-V	`5869273`	`00195278303196`	1	On the market
BE9CS-D	BE9CS-D	`H40482LE`	`00840682110754`	1	On the market
BE9CS-RS	BE9CS-RS	`H40482LN`	`00840682117210`	1	On the market
C1-5-D	C1-5-D	`H40452LE`	`00840682110082`	1	On the market
C1-5-RS	C1-5-RS	`H40462LA`	`00840682110952`	1	On the market
C1-6-D	C1-6-D	`H40472LT　5418916`	`00840682112390`	1	On the market
C1-6VN-D	C1-6VN-D	`H40472LW, 5476278`	`00840682110716`	1	On the market
C2-9-D	C2-9-D	`H40462LN, 5405253`	`00840682109994`	1	On the market
C2-9VN-D	C2-9VN-D	`H40472LY, 5488221`	`00840682110631`	1	On the market
C3-10-D	C3-10-D	`H40482LB, 5493011`	`00840682110655`	1	On the market
Deep Learning Image Reconstruction	Deep Learning Image Reconstruction	`5869275`	`00195278303202`	1	On the market
Deep Learning Image Reconstruction	Deep Learning Image Reconstruction	`5928863`	`00195278620453`	1	On the market
E8C Reusable Guide Attachment	E8C Reusable Guide Attachment	`H40412LN, 5756502`	`00840682125840`	1	On the market
E8C-RS	E8C-RS	`H40402LN, 5318734`	`00840682106702`	1	On the market
ERB7/ERB Biopsy Attachment	ERB7/ERB Biopsy Attachment	`H40202E, 2266598`	`00840682125833`	1	On the market
IC5-9-D	IC5-9-D	`H40442LK`	`00840682108584`	1	On the market
IC5-9-D	IC5-9-D	`H40442LK`	`00840682116817`	1	On the market
L8-18i-D	L8-18i-D	`H40452LL, 5336965`	`00840682109895`	1	On the market

Product	Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
11L-D	11L-D	`5176269`	`00840682110372`	1	On the market
12L-RS	12L-RS	`H40402LY`	`00840682106870`	1	On the market
4Vc-D	4Vc-D	`H40482LS`	`00840682123860`	1	On the market
6Sc-D	6Sc-D	`H46462LS`	`00195278723963`	1	On the market
8C-RS	8C-RS	`H40402LS`	`00840682106962`	1	On the market
9L-D	9L-D	`H40442LM`	`00840682110334`	1	On the market
9L-RS	9L-RS	`H40442LL`	`00840682110006`	1	On the market
ASiR-V	ASiR-V	`5869273`	`00195278303196`	1	On the market
BE9CS-D	BE9CS-D	`H40482LE`	`00840682110754`	1	On the market
BE9CS-RS	BE9CS-RS	`H40482LN`	`00840682117210`	1	On the market
C1-5-D	C1-5-D	`H40452LE`	`00840682110082`	1	On the market
C1-5-RS	C1-5-RS	`H40462LA`	`00840682110952`	1	On the market
C1-6-D	C1-6-D	`H40472LT　5418916`	`00840682112390`	1	On the market
C1-6VN-D	C1-6VN-D	`H40472LW, 5476278`	`00840682110716`	1	On the market
C2-9-D	C2-9-D	`H40462LN, 5405253`	`00840682109994`	1	On the market
C2-9VN-D	C2-9VN-D	`H40472LY, 5488221`	`00840682110631`	1	On the market
C3-10-D	C3-10-D	`H40482LB, 5493011`	`00840682110655`	1	On the market
Deep Learning Image Reconstruction	Deep Learning Image Reconstruction	`5869275`	`00195278303202`	1	On the market
Deep Learning Image Reconstruction	Deep Learning Image Reconstruction	`5928863`	`00195278620453`	1	On the market
E8C Reusable Guide Attachment	E8C Reusable Guide Attachment	`H40412LN, 5756502`	`00840682125840`	1	On the market
E8C-RS	E8C-RS	`H40402LN, 5318734`	`00840682106702`	1	On the market
ERB7/ERB Biopsy Attachment	ERB7/ERB Biopsy Attachment	`H40202E, 2266598`	`00840682125833`	1	On the market
IC5-9-D	IC5-9-D	`H40442LK`	`00840682108584`	1	On the market
IC5-9-D	IC5-9-D	`H40442LK`	`00840682116817`	1	On the market
L8-18i-D	L8-18i-D	`H40452LL, 5336965`	`00840682109895`	1	On the market

GE Healthcare Japan Corporation

About GE Healthcare Japan Corporation

Contact details for GE Healthcare Japan Corporation

Competent authority

Officers and regulatory representatives of GE Healthcare Japan Corporation

Related searches

About GE Healthcare Japan Corporation

Contact details for GE Healthcare Japan Corporation

Competent authority

Officers and regulatory representatives of GE Healthcare Japan Corporation

Approved members

Statistics for GE Healthcare Japan Corporation

Certificate health for GE Healthcare Japan Corporation

Issuing notified bodies

Related documents

Devices by risk class

Device catalog for GE Healthcare Japan Corporation

Device families (Basic UDI-DI) of GE Healthcare Japan Corporation

Market presence of GE Healthcare Japan Corporation

Connected operators

Importers

Authorised representatives

Related searches

Market presence of GE Healthcare Japan Corporation

Devices by risk class

Device families (Basic UDI-DI) of GE Healthcare Japan Corporation

Statistics for GE Healthcare Japan Corporation

Issuing notified bodies

Certificate health for GE Healthcare Japan Corporation

Approved members

Related documents

Connected operators

Importers

Authorised representatives

Device catalog for GE Healthcare Japan Corporation