Breastcare
- Risk class
- Class I
- CND nomenclatures code
- V9099
- Trade name
- Silk Flex Darktone Size 13
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00643293033661
- Basic UDI
- 00643293Breastcare6Z
- Version date
- November 07, 2024
- Manufacturer last update
- April 18, 2024
- Active status
- No
- Manufacturer name
- Trulife
- Country
- Ireland
- Country type
- EU_MEMBER_STATE
- Address
- Airton Road Dublin 24
- Quality_department@trulife.com
- Competent authority
- Health Products Regulatory Authority, Medical Devices Department
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Ireland
- Market available
- Austria:None~None, Estonia:None~None, Germany:None~None, Greece:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Lithuania:None~None, Malta:None~None, Netherlands:None~None, Poland:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
- Human tissues
- No
- Animal tissues
- No
VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Access comprehensive regulatory information for Breastcare in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00643293033661 and manufactured by Trulife in Ireland.
This page provides complete registration details including trade name (Silk Flex Darktone Size 13), manufacturer information, competent authority (Health Products Regulatory Authority, Medical Devices Department), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.