EUDAMED registration 06950617415299No

Automatic Hematology Analyzer LH-5 Lysing Reagent A

Name: Automatic Hematology Analyzer LH-5 Lysing Reagent A — EUDAMED registration 06950617415299
Creator: Maccura Biotechnology Co., Ltd.
Keywords: Automatic Hematology Analyzer LH-5 Lysing Reagent A, 06950617415299, Automatic Hematology Analyzer LH-5 Lysing Reagent A, Class A, Maccura Biotechnology Co., Ltd. , EUDAMED registration

Maccura Biotechnology Co., Ltd. Class AEU EUDAMEDTrade name: Automatic Hematology Analyzer LH-5 Lysing Reagent A

VerifiedEUDAMED · official EU database

Device classification

Risk class: Class A
CND nomenclatures code: W0103010105
Trade name: Automatic Hematology Analyzer LH-5 Lysing Reagent A
Implantable: No
Reusable: No
Measuring function: No

Registration information

Primary DI: 06950617415299
Basic UDI: 69506174BL2200066S
Version date: February 14, 2025
Manufacturer last update: November 23, 2023
Active status: No

Manufacturer

Manufacturer name: Maccura Biotechnology Co., Ltd.
Country: China
Country type: NON_EU
Address: 16#, Baichuan Road, Hi-tech Zone, Chengdu
Email: maccura@maccura.com

Authorized representative

Name: CMC Medical Devices & Drugs SL
SRN: ES-AR-000000293
Country: Spain
Address: C/ Horacio Lengo N18 Málaga
Email: info@cmcmedicaldevices.com
Telephone: +34951214054

Regulatory information

Competent authority: Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation: IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed on the market: Türkiye
Market available: Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None

Device characteristics

Human tissues: No
Animal tissues: No

Device description (EMDN)

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

About this record

Access comprehensive regulatory information for Automatic Hematology Analyzer LH-5 Lysing Reagent A 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 06950617415299 and manufactured by Maccura Biotechnology Co., Ltd. in China.

This page provides complete registration details including trade name (Automatic Hematology Analyzer LH-5 Lysing Reagent A), 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.