Private-Label Blood Pressure MonitorsMOQ 1,000Republic of KoreaIn stock
Our established monitor platforms, supplied under your brand and design.
MOQ 1,000
OEM & Regulatory Support
Regulatory Technical File Support
SKU · DOC-SUPPORTIn stockSamples availableHelp preparing the technical files and test reports needed for registration in your market.
Minimum order quantity1000
Lead timeBy agreement
Country of originRepublic of Korea
PackingElectronic files
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Description
Product specifications, the ISO 14971 risk management file, electrical safety and EMC test reports and translated instructions for use are prepared as one package. Registration roles and procedures differ by country, so we confirm them with you first.
Specification
Three items on record
| Documents | Specifications, risk file, test reports, IFU |
|---|---|
| Test standards | IEC 60601-1, IEC 60601-1-2 |
| Preparation time | 6–8 weeks |
Certifications & records
Two documents on file
CertifiedISO 13485:2016IEC 60601-1
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