Product safety


Manufacturer details in accordance with § 6 ProdSG and Art. 20 GPSR

Manufacturer

Armbrüster Consulting GmbH
Kardena

Marienstr. 5
26180 Rastede
Germany

Responsible for all proprietary Kardena brand products in accordance with GPSR Art. 11


Product Safety & Instructions

Section Safety instructions
Intended use This product is intended exclusively for use on the human body in accordance with the operating manual. Medical diagnostics or therapeutic use shall only take place if the product is classified as a medical device.
General safety and warning notices
  • Protect from heat, direct sunlight, and moisture
  • Do not use if the product is visibly damaged
  • Keep away from children (choking hazard)
Electrical safety
  • Charge only with the original charging cable or approved accessories
  • Do not charge if in contact with water
  • Connect only to suitable power sources
Wearing and hygiene tips
  • Do not wear the wristband too tightly for extended periods
  • Clean regularly (according to instructions)
  • Remove immediately in case of skin irritation
Environment & disposal
  • Dispose of via certified collection points in accordance with ElektroG & BattG
  • Do not dispose of old batteries in household waste
Maintenance & repair
  • Do not perform unauthorised repairs or opening
  • Use only authorised specialised personnel
Disclaimer
  • Not a substitute for professional medical care
  • No liability in the event of disregard of instructions
Legal consequences of violations Failure to comply may void the warranty. Health risks may occur. In the event of damage, product liability may be voided (Art. 9, GPSR).


Product Overview & Traceability

Product / Designation Model / Serial number
Kardena CARE CRE1
Kardena CARE Plus PLS1
Kardena CARE Plus 2 PLS2
Kardena CARE Pro 1 PRO1
Kardena CARE Pro 2 PRO2
Kardena CARE Pro 2 Connect PROC
Kardena CARE Pro 3 PRO3
Kardena CARE Air 3 SA3
Kardena CARE Control CC1
Kardena CARE Control 2 CC2
Kardena CARE SOS 1 SOS1
Kardena CARE SOS 2 SOS2
Kardena CARE Pro 4 PRO4
Kardena CARE Pro 4 Plus PRO4+
Kardena CARE One ONE1
Kardena CARE Life CL1
Kardena CARE Armband CB1
Kardena CARE Pro 5 PRO5
Kardena CARE One 2 ONE2
Kardena CARE GPS GPS1
Kardena Nagel Vitallicht NV
Kardena CARE SOS 3 SOS3


Symbol labelling & safety icons

Symbol 1


Manufacturer details for Kardena MED medical devices

Product name Manufacturer EU Authorized Representative
Kardena MED: AST-905B Shenzhen OSTO Medical Technology Co., LTD Phoenix Medtech GmbH, Königsberger Strasse 11, 64839 Münster, Germany
Kardena MED: AST-2012B Shenzhen OSTO Medical Technology Co., LTD Phoenix Medtech GmbH, Königsberger Strasse 11, 64839 Münster, Germany
Kardena MED: AST-300V Shenzhen OSTO Medical Technology Co., LTD Phoenix Medtech GmbH, Königsberger Strasse 11, 64839 Münster, Germany
Kardena MED: O2 Ring Shenzhen Viatom Technology Co., Ltd. MedNet EC-REP GmbH, Borkstrasse 10, 48163 Münster, Germany
Kardena MED: DuoEK S Shenzhen Viatom Technology Co., Ltd. MedNet EC-REP GmbH, Borkstrasse 10, 48163 Münster, Germany
Kardena MED: BP3-C2 Shenzhen Viatom Technology Co., Ltd. MedNet EC-REP GmbH, Borkstrasse 10, 48163 Münster, Germany
Kardena MED: BP2 Shenzhen Viatom Technology Co., Ltd. MedNet EC-REP GmbH, Borkstrasse 10, 48163 Münster, Germany


Further legal notices

  • All products are delivered with operating instructions in German.
  • Armbrüster Consulting GmbH is the manufacturer within the meaning of the GPSR for all private label products. For medical devices, Armbrüster Consulting GmbH is a distributor in accordance with MDR Art. 14.
  • Declarations of conformity and other legally required documents are available upon request (GPSR Art. 21, MDR Art. 10(6)).