Intended purpose of use: To listen to the foetal heart beat
Product description:
Foetal Stethoscope Pinard Monaural, for diagnosis and prenatal care of pregnant women to listen to the foetal heart.
Material: unbreakable plastic of aluminium
Monaural
1 piece
Length: approx. 150mm
Instructions for use:
For diagnosis and prenatal care of pregnant women to listen to the foetal heart.
Packaging and labelling:
One (1) foetal stethoscope in a plastic bag with manufacturer's instruction for use in English, French and Spanish.
Symbols used according ISO 15223
CE mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
Must comply with following standards
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing.
Environmental requirements:
ISO 14001
Chemicals used shall not be ""Carcinogenic, Mutagenic of Toxic to Reproduction, Persistent & Bio accumulative types"".
PVC is not recommended
Product description:
Foetal Stethoscope Pinard Monaural, for diagnosis and prenatal care of pregnant women to listen to the foetal heart.
Material: unbreakable plastic of aluminium
Monaural
1 piece
Length: approx. 150mm
Instructions for use:
For diagnosis and prenatal care of pregnant women to listen to the foetal heart.
Packaging and labelling:
One (1) foetal stethoscope in a plastic bag with manufacturer's instruction for use in English, French and Spanish.
Symbols used according ISO 15223
CE mark
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
Must comply with following standards
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing.
Environmental requirements:
ISO 14001
Chemicals used shall not be ""Carcinogenic, Mutagenic of Toxic to Reproduction, Persistent & Bio accumulative types"".
PVC is not recommended
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $2.18 |
