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360° Service for Medical Devices: STK, MTK, DGUV V3, Maintenance, Repair, and Distribution of POCT and Laboratory Equipment

LÖ

Löwe Medizintechnik

Hauptstraße 27, 87448 Waltenhofen (DE)New on Amplifa

1985Founded
ca. 3.000 KundenCustomer Support Nationwide
DIN EN ISO 13485:2016QM Certification
Hauptstraße 27, 87448 WaltenhofenHeadquarters

Comprehensive Service for Medical Technology

Löwe Medizintechnik is a sole proprietorship founded in 1985 and based in Waltenhofen (Bavaria), specializing in 360° service for medical devices in doctors' practices, medical practices centers (MVZ), and clinics. The range of services includes safety technical controls (STK) according to §12 MPBetreibV, measurement technical controls (MTK) for devices listed under MPBetreibV Annex 2, electrical device inspections according to DGUV V3, maintenance according to manufacturer specifications, repairs compliant with RKI disinfection guidelines, remote maintenance, as well as medical device management and documentation. Furthermore, the company distributes medical devices and laboratory equipment from the areas of Point-of-Care Diagnostics, urinalysis, hematology, biochemistry, blood gas and electrolyte analysis, and pediatrics (including transcutaneous bilirubin measuring devices) via a B2B shop. The quality management system is certified according to DIN EN ISO 13485:2016; the nationwide on-site service is performed by electrical specialists and trained technicians.

Site
Waltenhofen
Processes
STK (Safety Technical Controls) according to §12 MPBetreibV, Inspections according to DGUV V3 (electrical devices), Measurement Technical Controls (MTK, former Calibration) on devices listed under MPBetreibV Annex 2, Maintenance of medical devices according to manufacturer specifications, Repair of medical devices (after RKI disinfection), Service for Clinics (On-site inspections and maintenance), Remote Maintenance, Medical Device Management / Documentation Management
Materials
Safety Technical Controls (§12 MPBetreibV), Measurement Technical Controls (MPBetreibV Annex 2), Inspections according to DGUV V3 (BGV A3), Point-of-Care Diagnostics
Certificates
DIN EN ISO 13485:2016
Founded
1985
Industries
Doctors' Practices, MVZs, and Clinics, Point-of-Care Diagnostics, Pediatrics, Laboratory, Medical Technology Services for Doctors' Practices, MVZs, and Clinics
  1. 01

    Consulting and Practice Setup

  2. 02

    Medical Device Inventory Management

  3. 03

    Inspections (STK, MTK, DGUV V3) and Maintenance

  4. 04

    Repair and Remote Maintenance

  5. 05

    Documentation Management

  6. 06

    Distribution of Devices and Consumables

Testing and Measurement Procedures

STK

Safety Technical Controls (§12 MPBetreibV)

Legally mandated inspection of medical devices, including periodically maintained measuring devices.

MTK

Measurement Technical Controls (MPBetreibV Annex 2)

Legally sound inspection (formerly calibration) of blood pressure monitors, electric thermometers, and cycle ergometers.

DGUV V3

Inspections according to DGUV V3 (BGV A3)

Inspection of electrical devices and operating equipment by electrical specialists, including complete documentation.

POCT

Point-of-Care Diagnostics

Distribution of urinalysis, blood count, immunofluorescence, biochemistry, and blood gas analysis devices for practice and laboratory.

Location

Waltenhofen

DE

Headquarters, Service, and Sales

Materials
Medical devices, laboratory, and POCT devices
  • Testing aids for STK and MTK
  • Measuring devices for DGUV V3 inspections

Industries

Doctors' Practices, MVZs, and ClinicsPoint-of-Care DiagnosticsPediatricsLaboratoryMedical Technology Services for Doctors' Practices, MVZs, and Clinics

Processes & technical limits

ProcessesToleranceMax. partWeightLot sizeMaterials
STK (Safety Technical Controls) according to §12 MPBetreibVInspection–––––
Inspections according to DGUV V3 (electrical devices)Inspection–––––
Measurement Technical Controls (MTK, former Calibration) on devices listed under MPBetreibV Annex 2Inspection––––manual blood pressure monitors, digital blood pressure monitors, electric thermometers, cycle ergometers
Maintenance of medical devices according to manufacturer specificationsInspection–––––
Repair of medical devices (after RKI disinfection)Inspection–––––
Service for Clinics (On-site inspections and maintenance)Inspection–––––
Remote MaintenanceInspection–––––
Medical Device Management / Documentation ManagementEngineering–––––
Distribution of Medical Devices and Laboratory Equipment (POCT, Diagnostics, Therapy)Inspection–––––

20 Anlagen & Maschinen

MachineManufacturer / modelQuantityWorking areaYear builtSite
Urine Strip Analyzer (semi-automatic)AUR-400 Ultrona Plus––––
Urine Strip Analyzer (semi-automatic)AUR-600 Oriana Plus––––
Transcutaneous Bilirubin Measuring DeviceBM-100A––––
Transcutaneous Bilirubin Measuring DeviceBM-100C––––
Blood Count Analyzer (POC, 3-Diff + CRP/SAA)Dymind DP-H10––––
Mobile Fluorescence Immunoassay Blood Analysis SystemGenrui FA20––––
Multi-Channel Immunofluorescence Analyzer (12-Channel)Genrui FA30––––
Immunofluorescence Blood Analysis SystemGenrui FA50––––
Immunofluorescence Blood Analysis PlatformHumaFIA––––
Automatic Urine Microscope Analyzer with AI EvaluationHumaVision––––
Minilab (Hematology + Biochemistry)Ozelle EHBT-50––––
Automatic 7-Diff Hematology Analysis DeviceOzelle EHBT-75––––
Fully Automated Biochemistry Analysis DeviceSeamaty SD1––––
Portable Electrolyte AnalyzerSeamaty SE1––––
Portable Blood Gas and Electrolyte AnalyzerSeamaty SG1––––
Spot Vision Screener (Connection/Service)HillRom (WelchAllyn) SpotVision Screener––––
Connex Spot Monitor (Connection/Service)HillRom (WelchAllyn) CSM Connex Spot Monitor––––
Hematology Device (Connection/Service)MS4S––––
Hematology Device (Connection/Service)MS4Se––––
Urine Analyzer (Connection/Service)Clinitec Status––––

Additional services

STK according to §12 MPBetreibVMeasurement Technical Controls (MTK) according to MPBetreibV Annex 2Inspections according to DGUV V3 (BGV A3)Service for ClinicsMaintenanceRepairsRemote MaintenanceMedical Device ManagementDocumentation ManagementTraining on Risk Assessment in Doctors' PracticesPractice Setup and ConsultingSoftware Interface Connection (GDT 2.1) to AISDistribution of Medical Devices and Laboratory Equipment (B2B Shop)

Reference customers

Inovamed GmbH, Aachen (Google Review)Gemeinschaftspraxis am Rennplatz, Regensburg (Google Review)

Quality Assurance

Professional competence is regularly checked and demonstrated through DIN EN ISO 13485:2016 certification; all technicians are qualified electrical specialists or appropriately trained. For all medical devices to be inspected, a corresponding measuring device is available, which is checked and maintained annually.

EvidenceWaltenhofen
DIN EN ISO 13485:2016

History

  1. 1985

    Founding or start of activity as a partner for medical product law and occupational safety.

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