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Breastcare - EUDAMED Registration 00643293033630

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 00643293033630 and manufactured by Trulife in Ireland.

This page provides complete registration details including trade name (Silk Flex Darktone Size 10), 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.

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EUDAMED Official Data
Class I
00643293033630
No
Breastcare
Trade Name: Silk Flex Darktone Size 10
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Device Description (EMDN)

VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V9099
Trade Name
Silk Flex Darktone Size 10
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00643293033630
Basic UDI
00643293Breastcare6Z
Version Date
November 07, 2024
Manufacturer Last Update
April 18, 2024
Active Status
No
Manufacturer
Manufacturer Name
Trulife
Country
Ireland
Country Type
EU_MEMBER_STATE
Address
Airton Road Dublin 24
Email
Quality_department@trulife.com
Regulatory Information
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, Tรผrkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No