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Pathogen Multiplex-PCR Library Prep Kit - EUDAMED Registration 06977805760023

Access comprehensive regulatory information for Pathogen Multiplex-PCR Library Prep Kit in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06977805760023 and manufactured by Shenzhen Health SwifTech Co., Ltd. in China.

This page provides complete registration details including trade name (Pathogen Multiplex-PCR Library Prep Kit), manufacturer information, authorized representative details, competent authority (Agencia Espaรฑola de Medicamentos y Productos Sanitarios), 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 A
06977805760023
No
Pathogen Multiplex-PCR Library Prep Kit
Trade Name: Pathogen Multiplex-PCR Library Prep Kit
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Device Description (EMDN)

GENETIC TESTS - OTHER

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W010699
Trade Name
Pathogen Multiplex-PCR Library Prep Kit
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06977805760023
Basic UDI
697780576HSTAALIBTDZ
Version Date
September 26, 2024
Manufacturer Last Update
September 20, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.76 Baohe Avenue Shenzhen
Email
hildafangpmp@163.com
Authorized Representative
SRN
ES-AR-000019366
Country
Spain
Address
CARRER DE TAPIOLES, 33, 2- 1 Barcelona
Email
rep@themedunion.com
Telephone
+34644173535
Regulatory Information
Competent Authority
Agencia Espaรฑola de Medicamentos y Productos Sanitarios
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Tรผrkiye
Device Characteristics
Human Tissues
No
Animal Tissues
No