Development, manufacture and distribution of medical devices for contraception and sexual medicine

KESSEL medintim GmbH

Mörfelden-Walldorf (Kelsterbacher Str. 28) · Mörfelden-Walldorf (Nordendstr. 82-84, warehouse and shipping)New on Amplifa

1987Founded

2 sites in Mörfelden-WalldorfHeadquarters as well as warehouse and shipping

more than 45 countriesDistribution worldwide

About Medintim

KESSEL medintim GmbH, headquartered in Mörfelden-Walldorf near Frankfurt am Main, develops, produces and distributes medical devices for the fields of contraception and sexual medicine. The portfolio includes hormone-free contraceptives such as the Caya diaphragm, vacuum erection devices, lubricating and vaginal gels, hygiene products, fertility products, incontinence and sexual education products. Production takes place almost exclusively in Germany; distribution is via qualified distribution partners in more than 45 countries in Europe, the Middle East, Australia, Africa and North America. Materials used include latex, polyurethane, silicone and PVC; for sexual education teaching materials, models made of silicone, PVC and beech wood are also produced. Quality management is certified to DIN EN ISO 13485 as well as to the requirements of the EU Medical Device Regulation (MDR, Annex IX) and MDSAP for Australia, Brazil, Canada and the USA. The company was founded in 1987 and until 1997 traded as the distribution company of the Pro Familia association in Frankfurt am Main.

Site: Mörfelden-Walldorf
Processes: Development, manufacture and distribution of medical devices for contraception and sexual medicine, Metrological and safety inspections on general active medical devices, Quality management system according to DIN EN ISO 13485 / MDSAP (development, manufacturing,, Research and development of medical devices, Manufacturing of medical devices, Distribution, Sexual education teaching materials, Shop for sexual education (medintim-education.de)
Materials: Latex, Polyurethane, Silicone, PVC, Beech wood
Certificates: DIN EN ISO 13485:2021, DIN EN ISO 13485 (workshop, metrological/safety inspections), EU quality management certificate (Annex IX Chapters I & III, MDR 2017/745), ISO 13485:2016 MDSAP (AUS, BRA, CAN, USA), ISO 13485, MDR Annex IX (EU QM certificate), MDSAP (AUS, BRA, CND, USA)
Founded: 1987
Industries: Medical technology / Medical devices, Contraception, Sexual medicine, Healthcare / Pharmacies (PZN articles)

01
Research and development
02
Manufacturing
03
Metrological and safety inspections
04
Warehouse and shipping
05
Distribution via partners in more than 45 countries

Materials

Latex

Used for the ultra-thin protective sheet Oralsafe Latex for oral-genital contact.

Polyurethane

Latex-free alternative for protective sheets (Oralsafe PU Dam) for users with latex intolerance.

Silikon

Silicone

Used for models for sexual education and breast self-examination such as the MLS-2 Basic Set.

PVC

Used for teaching and anatomy models such as penis models for sexual education.

Holz

Beech wood

Material for the wooden penis model for sexual education.

Sites

Mörfelden-Walldorf headquarters

Headquarters: development, administration, distribution

Materials: Latex, polyurethane, silicone, PVC

Nordendstr. 82-84, Mörfelden-Walldorf

Development, manufacturing as well as warehouse and shipping

Materials: Latex, polyurethane, silicone, PVC

Products

**Caya Contoured diaphragm**Diaphragm for hormone-free contraception · Medical technology

**Active3 Erection System**Rechargeable vacuum erection device · Medical technology

**Female condom**Condom for women · Contraception

**Prosecca Band**Band against dribbling · Incontinence

**Bumpi Rings**Help with pain · Sexual medicine

**Waypi**Urinary funnel for on the go · Hygiene

**Premeno**Vaginal suppositories for vaginal dryness · Medical technology

**Vagiwell Dilators**Medical dilator sticks · Sexual medicine

**ActiveLoopRing**Adjustable constriction ring · Medical technology

**Caya Gel**Gel for use with diaphragms · Contraception

**Animé Lubricant**Intimate lubricant with hyaluron · Medical technology

**Backup Ring**Constriction ring for vacuum erection devices · Medical technology

Inside the production

Industries

Medical technology / Medical devicesContraceptionSexual medicineHealthcare / Pharmacies (PZN articles)

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Development, manufacture and distribution of medical devices for contraception and sexual medicineEngineering	–	–	–	–	Latex, Polyurethane, Silicone, PVC
Metrological and safety inspections on general active medical devicesTesting	–	–	–	–	–
Quality management system according to DIN EN ISO 13485 / MDSAP (development, manufacturing,Engineering	–	–	–	–	–

Additional services

Research and development of medical devicesManufacturing of medical devicesDistributionSexual education teaching materialsShop for sexual education (medintim-education.de)

Quality

The quality management system is certified to DIN EN ISO 13485 and covers two certificates: development, manufacture and distribution of medical devices for contraception and sexual medicine, as well as metrological and safety inspections on active medical devices. In addition, the EU quality management certificate in accordance with MDR Annex IX (Notified Body 0483) and the MDSAP for Australia, Brazil, Canada and the USA are in place.

Evidence	Kelsterbacher Str. 28	Nordendstr. 82-84
ISO 13485
MDR Annex IX (EU QM certificate)
MDSAP (AUS, BRA, CND, USA)

History

1987
Founded by Gertrud Halberstadt, Dr. med. K.O.K. Hoffmann and Martin Kessel as PROFAMILIA Vertriebsgesellschaft mbH & Co KG in Frankfurt am Main
1997
Exit of the partners from the Pro Familia association; continuation as KESSEL Marketing & Vertriebs GmbH
1999
Relocation of the company headquarters to Mörfelden-Walldorf near Frankfurt am Main
2014
Renaming to KESSEL medintim GmbH and realignment of corporate objectives to medical devices for contraception and sexual medicine
2016
Move into the new business premises at Nordendstr. 82-84 and cooperation with the company Distler Medizintechnik
2019
Merger of DISTLER Medizintechnik GmbH with KESSEL medintim GmbH; universal succession of DISTLER Medizintechnik GmbH