EU → North America Device Access

B. Braun Surgical, S.A.

ES-MF-000002083 · Spain · Rubí

B. Braun Surgical, S.A. is registered in the European database on medical devices as a manufacturer, with 89 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb89

Among these devices, 89 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 89 declared devices.

Catalogue references include C0840416, C0840424, C0840440, C0841587, C0842354, C0849383.

European nomenclature codes declared: H010201020201.

United States market access

FDA establishment registerRegistered with FDA
Matched entryB. BRAUN SURGICAL, S.A. (ES) · FDA 3025308493
Devices in EUDAMED89
Country of registrationSpain

Device-level evidence

Devices with a numeric GTIN89
Found in the U.S. device database88
Share98.9 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryB. BRAUN SURGICAL S.A.

North American profile: Both markets. B. Braun Surgical, S.A. is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
G11 025701 0102issued2027-07-18
G12 025701 0096supplemented2027-07-18
G10 025701 0095supplemented2027-07-18

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