EU Manufacturer 🇨🇳 China

hangzhou lysun biotechnology co.,ltd

SRN: CN-MF-000010254 · 6th floor,6th building,No.95 binwen road,xixing street,binjiang district, 310051 Hangzhou, China
Basic UDI-DIs
41
Total Devices
41
On Market
40
Off Market
1
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
2

Basic Information

Address
6th floor,6th building,No.95 binwen road,xixing street,binjiang district, 310051 Hangzhou, China

Regulatory Overview

Regulation
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Eu Ivdd 39
Eu Ivdr 2
Classification
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Eu Ivd General 23
Eu Ivd Self Testing 16
Eu Ivd Class A 2
Device Types
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Certificate Health

Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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Type Number Expiry Date Status
IVDD Annex IV (excluding sections 4, 6) V1 101151 0002 May 26, 2024
IVDD Annex IV (excluding sections 4, 6) V1 101151 0002 May 26, 2024

Market Presence

Devices from this manufacturer are available in 2 countries across Europe.

🇩🇪 Germany 🇫🇷 France

Device Portfolio

Name
BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
CHOLESTEROL TEST STRIPS
CORONAVIRUS [obsolete from 2025-01-01]
CORONAVIRUS [obsolete from 2025-01-01]
CORONAVIRUS [obsolete from 2025-01-01]
CORONAVIRUS [obsolete from 2025-01-01]
CORONAVIRUS [obsolete from 2025-01-01]
CREATININE ANALYSIS TEST STRIPS
Creatinine Test Strip(Dry Chemistry)
GLUCOSE TEST STRIPS
GLUCOSE TEST STRIPS
GLUCOSE TEST STRIPS
HDL TEST STRIPS
Influenza A+B/COVID-19/ RSV Antigen Rapid Test
Liver Function Analysis Meter
Lysun
MULTIPLE PARAMETERS POC CONTROLS
MULTIPLE PARAMETERS POC CONTROLS
Multi-function analyzer (blood glucose, uric acid, lipids, blood pressure)
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES
Renal Function Analysis Meter
TRIGLYCERIDE TEST STRIPS
UREA TEST STRIPS
VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER