Announced details
Medical devices, European expansion, and overseas expansion including Asia and South America
The Company is working with external specialists to prepare for responding to the certification body.
MDR (European Medical Device Regulation) certification
Certification body (name not disclosed)
The impact of this matter on results for the current fiscal year is currently expected to be minor.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | CADD Amy PCA |
| Relationship with the Company | The Company is working with external specialists to prepare for responding to the certification body. |
| Applicable area | Medical devices, European expansion, and overseas expansion including Asia and South America |
| Award/certification name | MDR (European Medical Device Regulation) certification |
| Awarding / certifying body | Certification body (name not disclosed) |
| Impact on Business Performance | The impact of this matter on results for the current fiscal year is currently expected to be minor. |
Items this document does not state (12)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The Company is undertaking additional work for the clinical evaluation, preparing the PMCF plan and application documents, and preparing to respond to the certification body in connection with obtaining MDR certification in Europe. As the timing of certification depends on factors including the certification body's review process, it is difficult to forecast a specific timeframe.