EU Manufacturer
๐จ๐ณ 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
- [email protected]
- Phone
- +86-731-88883176-6116
- Website
- www.sansureglobal.com
Regulatory Overview
Regulation
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Eu Ivdd
1205
Eu Ivdr
47
Classification
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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
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Certificate Health
Total
8
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
8
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 074552 0011 Rev. 02 | TรV SรD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV Section 4 | CeCert/115/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CeCert/116/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | CeCert/117/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CeCert/118/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | CeCert/119/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CeCert/120/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex III Section 6 | 1434-IVDD-260/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Market Presence
Devices from this manufacturer are available in 17 countries across Europe.
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden