EU Manufacturer
๐จ๐ณ China
Active
Hangzhou Laihe Biotech Co., Ltd.
SRN: CN-MF-000033566
ยท
Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District,, 310051 Hangzhou, Zhejiang, China
Basic UDI-DIs
6
Total Devices
6
On Market
6
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
4
Basic Information
- Address
- Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District,, 310051 Hangzhou, Zhejiang, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdr
4
Eu Ivdd
2
Classification
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Eu Ivd Class C
3
Eu Ivd Self Testing
2
Eu Ivd Class 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Expired / Withdrawn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 III Section 6 | CeCert/068/W/E.2 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | HL 2069313-1 | TรV Rheinland LGA Products GmbH | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 4 countries across Europe.
๐ฉ๐ช Germany
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ณ๐ฑ Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Chlamydia Antigen Rapid Test Kit | EU IVDR | Eu Ivd Class C | On Market | 0 |
| DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| GONOCOCCAL ANTIGEN DETECTION | EU IVDR | Eu Ivd Class C | On Market | 0 |
| LYHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPPโฆ.) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01] | EU IVDR | Eu Ivd Class C | On Market | 0 |