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Boston Scientific Corporation

Manufacturer of medical devices registered in the European database in Marlborough, United States.

Registration number (SRN)	US-MF-000004702
Role	Manufacturer
Status	Active
Country	United States
City	MA 01752 Marlborough
Address	Boston Scientific Way, 300 MA 01752 Marlborough
Registered on	2021-05-21

United States market access

FDA establishment register	Registered with the U.S. FDA
Matched entry	Boston Scientific Corporation (CA) · FDA 3019751610

Notified body certificates

Certificate	Status	Expiry	Type	Body
G70 097167 0040	cancelled	2028-03-22	Technical documentation	NB 0123
G12 097167 0051	cancelled	2028-04-05	Quality management system	NB 0123
G11 097167 0049	cancelled	2028-04-05	Quality management system	NB 0123
G10 097167 0039	cancelled	2028-04-05	Quality management system	NB 0123
40355	supplemented	2027-08-02	Quality management system	NB 0459
39506	supplemented	2027-08-02	Quality management system	NB 0459
3829852CE01	restricted	2027-06-01	Quality management system	NB 0344
3827895TD03	valid	2028-07-07	Technical documentation	NB 0344

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.