EU Manufacturer
🇨🇳 China
Active
Merlin Biomedical (Xiamen) Co., Ltd.
SRN: CN-MF-000021840
·
4th Floor, Building B3, 2054 West Wengjiao Rd, 361028 Haicang, Xiamen, China
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- 4th Floor, Building B3, 2054 West Wengjiao Rd, 361028 Haicang, Xiamen, China
- [email protected]
- Phone
- 86-592-5210772
- Website
- http://www.merlinbio.com.cn
Regulatory Overview
Regulation
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Eu Ivdd
1
Classification
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Eu Ivd Self Testing
1
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/037/W/E.1 | CeCert Sp. z o.o. | May 27, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| SARS-CoV-2 Antigen Rapid Test Cassette | EU IVDD | Eu Ivd Self Testing | On Market | 1 |