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Neo-Flex Thermal Wrap - EUDAMED Registration 06973596010804

Access comprehensive regulatory information for Neo-Flex Thermal Wrap 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 06973596010804 and manufactured by Conlett Technology Inc in China.

This page provides complete registration details including trade name (Neo-Flexi Thermal wrap), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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
06973596010804
No
Neo-Flex Thermal Wrap
Trade Name: Neo-Flexi Thermal wrap
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Device Description (EMDN)

NEONATAL INCUBATORS - CONSUMABLES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z1208040385
Trade Name
Neo-Flexi Thermal wrap
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06973596010804
Basic UDI
697359601FTWVU
Version Date
November 11, 2024
Manufacturer Last Update
March 15, 2021
Active Status
No
Manufacturer
Manufacturer Name
Conlett Technology Inc
Country
China
Country Type
NON_EU
Address
908, 9/F, Building 2, 28 Pingguoyuan Lu, Shijingshan District Beijing
Email
vico_sue@conlett.com.cn
Authorized Representative
SRN
NL-AR-000000121
Country
Netherlands
Address
Koningin Julianaplein 10, 1e Verd The Hague
Email
info@lotusnl.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
United Kingdom (Northern Ireland only)
Device Characteristics
Human Tissues
No
Animal Tissues
No