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Neo-Oris - EUDAMED Registration 06973596010422

Access comprehensive regulatory information for Neo-Oris 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 06973596010422 and manufactured by Conlett Technology Inc in China.

This page provides complete registration details including trade name (Neo-Oris 75ml), 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
06973596010422
No
Neo-Oris
Trade Name: Neo-Oris 75ml
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Device Description (EMDN)

URINE COLLECTION BAGS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
A06030301
Trade Name
Neo-Oris 75ml
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06973596010422
Basic UDI
697359601NeoOris58
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
Poland
Device Characteristics
Human Tissues
No
Animal Tissues
No