EU Manufacturer ๐Ÿ‡จ๐Ÿ‡ณ China Active

Sansure Biotech Inc.

SRN: CN-MF-000011392 ยท Lusong Road, Yuelu District No.680, 410205 Changsha, Hunan Province, China
Basic UDI-DIs
1252
Total Devices
1376
On Market
1334
Off Market
42
Certificates
8
Valid
0
Expiring < 6mo
0
Countries
17

Basic Information

Address
Lusong Road, Yuelu District No.680, 410205 Changsha, Hunan Province, China

Regulatory Overview

Regulation
Loading...
Eu Ivdd 1205
Eu Ivdr 47
Classification
Loading...
Eu Ivd General 1195
Eu Ivd Class A 42
Eu Ivd Class C 5
Eu Ivd Self Testing 4
Eu Ivd Annex 2 List A 3
Eu Ivd Annex 2 List B 3
Device Types
Loading...

Certificate Health

Total
8
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
8
Certificates by Expiry Year
Loading...
Type Number Expiry Date Status
IVDD Annex IV (excluding sections 4, 6) No. V1 074552 0011 Rev. 02 May 26, 2025
IVDD Annex IV Section 4 CeCert/115/W/E.1 May 26, 2025
IVDD Annex IV (excluding sections 4, 6) CeCert/116/W/E.1 May 26, 2025
IVDD Annex IV Section 4 CeCert/117/W/E.1 May 26, 2025
IVDD Annex IV (excluding sections 4, 6) CeCert/118/W/E.1 May 26, 2025
IVDD Annex IV Section 4 CeCert/119/W/E.1 May 26, 2025
IVDD Annex IV (excluding sections 4, 6) CeCert/120/W/E.1 May 26, 2025
IVDD Annex III Section 6 1434-IVDD-260/2022 May 27, 2025

Market Presence

Devices from this manufacturer are available in 17 countries across Europe.

๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden

Device Portfolio

Name
Autoantibody against Thyroglobulin Assay Kit (Chemiluminescent Immunoassay)
Autoantibody against Thyroglobulin Assay Kit (Chemiluminescent Immunoassay)
Detection Kit for 5 Mutations of SARS-CoV-2 (PCR-Fluorescence Probing)
Detection Kit for 5 Mutations of SARS-CoV-2 (PCR-Fluorescence Probing)
Influenza A/B Virus RNA Diagnostic Kit (PCR-Fluorescence Probing)
Influenza BV/BY RNA Diagnostic Kit๏ผˆPCR-Fluorescence Probing๏ผ‰
Influenza BV/BY RNA Diagnostic Kit๏ผˆPCR-Fluorescence Probing๏ผ‰
Monkeypox Virus (MPV) Rapid Antigen Test Kit (Colloidal Gold Method)
SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
15 High-risk Human Papillomavirus DNA (Genotype) Diagnostic Kit (PCR-Fluorescence Probing)
15 High-risk Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)
15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
15 High-risk Human Papillomavirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
25-HYDROXYVITAMIN D
25-HYDROXYVITAMIN D
25-HYDROXYVITAMIN D
25-HYDROXYVITAMIN D
25-HYDROXYVITAMIN D
25-HYDROXYVITAMIN D
25-HYDROXYVITAMIN D
25-HYDROXYVITAMIN D
ADENOVIRUS
ADENOVIRUS
ADENOVIRUS
ADENOVIRUS - NA REAGENTS
ADENOVIRUS - NA REAGENTS
ADENOVIRUS - NA REAGENTS
ADENOVIRUS - NA REAGENTS
ADENOVIRUS - NA REAGENTS
ADENOVIRUS - NA REAGENTS
ADENOVIRUS - NA REAGENTS
ADENOVIRUS - NA REAGENTS
ADENOVIRUS - NA REAGENTS
ADRENOCORTIOTROPIC HORMONE
ADRENOCORTIOTROPIC HORMONE
ADRENOCORTIOTROPIC HORMONE
ADRENOCORTIOTROPIC HORMONE
ADRENOCORTIOTROPIC HORMONE
ADRENOCORTIOTROPIC HORMONE
ALPHAFETOPROTEIN
ALPHAFETOPROTEIN
ALPHAFETOPROTEIN
ALPHAFETOPROTEIN
ALPHAFETOPROTEIN
ALPHAFETOPROTEIN
ALPHAFETOPROTEIN