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Hailife POC Hematology Analyer - EUDAMED Registration 06977254770093

Access comprehensive regulatory information for Hailife POC Hematology Analyer 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 06977254770093 and manufactured by Shenzhen Hailife Biotechnology Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Agencia Española 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
IVD General
06977254770093
No
Hailife POC Hematology Analyer
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W02010299
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06977254770093
Basic UDI
B-06977254770093
Version Date
September 12, 2024
Manufacturer Last Update
June 24, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.22 Jinxiu Road Shenzhen
Email
linpei@hailife.com.cn
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 Española de Medicamentos y Productos Sanitarios
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
No