Development and manufacture of mobile infusion pumps as well as services for medical devices up to approval
Lenus Infusionstechnik GmbH & Co. KG
Kiel (Main Northern Office) · Rottweil (Southern Branch)New on Amplifa
Company
Lenus Infusionstechnik GmbH & Co. KG develops and produces mobile infusion pumps for outpatient and inpatient infusion therapies. The product portfolio comprises the variants Lenus PCA for pain therapy, Lenus E for oncology, Lenus PCA Klinik with integrated drug reservoir and Lenus TPN for parenteral nutrition and antibiotic therapy. In addition, tubing sets for infusion pumps (risk class IIa) are manufactured. As a service, the company takes on the development of medical devices including design validation, verification and preparation of the technical product file, production under controlled conditions including validations up to sterilisation, as well as cleaning and packaging in cleanrooms of classes ISO 7 and ISO 8. This is complemented by QM and approval services, logistics for outpatient infusion therapies, device training in accordance with MPBetreibV, and the distribution of pharmaceuticals based on the wholesale distribution licence in accordance with § 52a AMG. The main Northern office with development, production and sales is located in Kiel, and a Southern branch with a sales office and warehouse is located in Rottweil.
- Site
- Kiel
- Processes
- Development and design of medical devices including design validation, verification and preparation, Production of medical devices under controlled conditions including all validations up to, Cleaning and packaging of medical devices in cleanrooms of classes ISO 7 and ISO 8, Manufacture of infusion pumps (Lenus E, Lenus PCA, Lenus PCA Klinik, Lenus TPN), Manufacture of tubing sets for infusion pumps (risk class IIa), Manufacture of iliac crest biopsy needles (historical, Stumpp Medizintechnik), Development of safety port needles (historical, OMT), Medical device development including design validation, verification and technical product file
- Materials
- Medical device development, Medical device production, Cleanroom ISO 7 / ISO 8, QM and approval service
- Certificates
- DIN EN ISO 13485:2016 (+ AC:2018 + A11:2021), EU 2017/745 MDR Annex IX (QMS), EC Certificate Directive 93/42/EEC Annex II (Lenus infusion pumps), ISO 13485, EU MDR 2017/745 Annex IX
- Founded
- 2012
- Industries
- Medical technology, Oncology, Pain therapy/anaesthesia, Parenteral nutrition, Antibiotic therapy, Immunoglobulin therapy
- 01
Medical device development including design validation and verification
- 02
Preparation of the technical product file and approval by the notified body
- 03
Production under controlled conditions including validations up to
- 04
Cleaning and packaging in ISO 7/8 cleanrooms
- 05
Distribution, logistics and service for outpatient infusion therapies incl.
Processes & Services
Medical device development
Design validation, verification and preparation of the technical product file for approval.
Medical device production
Production under controlled conditions including all validations up to sterilisation.
Cleanroom ISO 7 / ISO 8
Cleaning and packaging of medical devices, with organisation of sterilisation on request.
QM and approval service
Support with technical documentation and approvals at the notified body.
Locations
Kiel
DEMain Northern Office – development, production and sales
- ISO 7 cleanrooms
- ISO 8 cleanrooms
Rottweil
DESouthern Branch – sales office & warehouse
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development and design of medical devices including design validation, verification and preparationEngineering | – | – | – | – | – |
| Production of medical devices under controlled conditions including all validations up toAssembly | – | – | – | – | – |
| Cleaning and packaging of medical devices in cleanrooms of classes ISO 7 and ISO 8Surface | – | – | – | – | – |
| Manufacture of infusion pumps (Lenus E, Lenus PCA, Lenus PCA Klinik, Lenus TPN)Assembly | – | – | – | – | – |
| Manufacture of tubing sets for infusion pumps (risk class IIa)Assembly | – | – | – | – | – |
| Manufacture of iliac crest biopsy needles (historical, Stumpp Medizintechnik)Assembly | – | – | – | – | – |
| Development of safety port needles (historical, OMT)Engineering | – | – | – | – | – |
Additional services
Quality
The quality management system is certified in accordance with DIN EN ISO 13485:2016 and meets the requirements of EU MDR 2017/745 (Annex IX) and previously of Directive 93/42/EEC. Certifications are carried out by mdc medical device certification GmbH (Notified Body 0483).
| Evidence | Kiel | Rottweil |
|---|---|---|
| ISO 13485 | ||
| EU MDR 2017/745 Annex IX |
History
- 1997
Founding of Stumpp Medizintechnik GmbH (sales of infusion technology in the homecare sector, manufacture of iliac crest biopsy needles)
- 2000
Founding of OMT (sales of infusion technology, neuromodulation, development of safety port needles)
- 2012
Founding of Lenus Infusionstechnik GmbH & Co. KG – development and manufacture of infusion pumps
- 2015
Sale of OMT and Stumpp Medizintechnik to Air Liquide
- 2020
Approval of 3 infusion pumps for anaesthesia & pain therapy, oncology and TPN
- 2021
Distribution of the infusion pumps Lenus PCA, Lenus E and Lenus TPN; granting of the wholesale distribution licence for pharmaceuticals pursuant to § 52a AMG
- 2022
Move into the new Southern branch in Rottweil (sales office & warehouse)