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Gastrin-17 (G17) Test Kit (Fluorescence Immunochromatographic Assay) - EUDAMED Registration D-K90411-043PF

Access comprehensive regulatory information for Gastrin-17 (G17) Test Kit (Fluorescence Immunochromatographic Assay) in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI D-K90411-043PF and manufactured by SHENZHEN REETOO BIOTECHNOLOGY CO., LTD in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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
IVD General
D-K90411-043PF
No
Gastrin-17 (G17) Test Kit (Fluorescence Immunochromatographic Assay)
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

GASTRIN

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0102069001
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-K90411-043PF
Basic UDI
B-K90411-043PF
Version Date
July 04, 2022
Manufacturer Last Update
August 16, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
F406, Building F, Huafeng International Robot Industrial Park, Hangcheng Avenue, Nanchang Community, Xixiang Street, Bao'an District Not applicable Shenzhen
Email
service@reetoo.com.cn
Authorized Representative
SRN
NL-AR-000000444
Country
Netherlands
Address
Treubstraat 1 Rijswijk
Email
ar@umedwings.eu
Telephone
+31 (0) 642758955
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Italy
Device Characteristics
Human Tissues
No
Animal Tissues
Yes