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EUDAMED registration 26972129850225No

HE Stain Kit

Hunan Lituo Biotechnology Co., Ltd.Class AEU EUDAMEDTrade name: HE Stain Kit
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class A
CND nomenclatures code
W01030799
Trade name
HE Stain Kit
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
26972129850225
Basic UDI
697212985HESKNE
Active status
No
Manufacturer
Country
China
Country type
NON_EU
Address
No.129, Weiluoke Road Changsha
Email
market@lituo.com.cn
Authorized representative
SRN
ES-AR-000000293
Country
Spain
Address
C/ Horacio Lengo N18 Málaga
Email
info@cmcmedicaldevices.com
Telephone
+34951214054
Regulatory information
Competent authority
Agencia Española de Medicamentos y Productos Sanitarios
Applicable legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

HISTOLOGY / CYTOLOGY REAGENTS - OTHER

About this record

Access comprehensive regulatory information for HE Stain 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 26972129850225 and manufactured by Hunan Lituo Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (HE Stain Kit), 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.