July 2023 – Chordae Loops available again!

As you know, it was unfortunately not possible for us to have the Chordae Loops certified according to MDR until now. Since the MDD certificate for our products expired in 2021, this constitutes a non-compliance according to Art. 97 of Regulation 2017/745 (MDR).

An application subsequently submitted to the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte / BfArM) came to the conclusion after a thorough review that the non-conformity does not pose an unacceptable risk, and the products may be placed on the German market again with immediate effect, albeit without CE marking. Our partner Internacional Farmaceutica S.A. de C.V. in Mexico is of course still working on a certification according to MDR.

We are looking forward to supplying you again. All known sizes are still available.
If you have any questions, please do not hesitate to contact our team.

May 2022 – Change in the management

After almost 20 years in the position of managing director, Mr. Detlev-Sven Neumann will enter into his well-deserved retirement on 01.01.2023.

For this reason, as of 4th April 2022, the management will pass to our long-time employee Ms. Patricia Gerlach. Ms. Gerlach has already completed her apprenticeship in our company and has decided to continue to support Santec after successfully completing her study.

In the past years, she has already been a successful member of management. We are convinced that she will do everything in her power to realign our company with a view to the future and to overcome current hurdles.

Of course, Mr. Neumann will accompany Santec in an advisory capacity until his retirement.

September 2020 – Santec merger with International Farmacéutica S. A.

Santec Medicalprodukte GmbH has been known for many years as a specialist in the field of cardiovascular surgery. Due to the increasing requirements in the regulatory area, new financial challenges are consistently arising, which Santec would like to compensate for by increasing international sales activities, among other things.

During this process, numerous contacts to suture material distributors/manufacturers worldwide have been established already in order to promote internationalization – among others with Atramat from Mexico, who are also looking to expand their sales activities in the area of “general surgical sutures” to Europe and especially Germany.

After various discussions and considering the aspect of the age-related succession issue at the shareholder level of Santec, a takeover by International Farmacéutica, S. A. in Mexico, with the brand name “Atramat®“, was agreed upon as of 01.01.2020. Atramat® has existed as an owner-managed company for over 50 years and would like to maintain or expand the product range for cardiovascular surgery at the production site in Germany.

This has created a “win-win situation” for both companies, as Santec can benefit from Atramat®‘s international contacts while Atramat® complement their existing general surgical suture portfolio with cardiac surgery products and implants from Santec.

In addition, Santec, as a long-standing German manufacturer, offers Atramat® access to German-speaking countries with its own CE approvals. Joint sales activities will be coordinated in 2020 and the know-how on both sides will be used to win new customers and/or convince existing customers of new products from Atramat® and Santec.

Santec Medicalprodukte GmbH

Detlev-Sven Neumann, CEO