EU Manufacturer
π¨π³ China
Active
Sanway Gene Tech. Inc.
SRN: CN-MF-000037912
Β·
Lusong Road, Hi-Tech Development Zone, Yuelu District 5th Floor, Testing Building, No.680, 410205 Changsha, Hunan Province, China
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
3
Watch Sanway Gene Tech. Inc. for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- Lusong Road, Hi-Tech Development Zone, Yuelu District 5th Floor, Testing Building, No.680, 410205 Changsha, Hunan Province, China
- [email protected]
- Phone
- +86-731-88883176-6116
- Website
- www.sansureglobal.com
Regulatory Overview
Regulation
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Eu Ivdd
1
Classification
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Eu Ivd Annex 2 List A
1
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Expired / Withdrawn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 Section 4 | 1434-IVDD-198/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-199/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Market Presence
Devices from this manufacturer are available in 3 countries across Europe.
π¬π· Greece
πͺπΈ Spain
π«π· France
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |