EU Manufacturer
🇨🇳 China
Active
Guilin Royalyze Medical Instrument Co., Ltd.
SRN: CN-MF-000038422
·
Li River Road, Qixing District 18, 541004 Guilin, China
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Li River Road, Qixing District 18, 541004 Guilin, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
5
Classification
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Eu Ivd Self Testing
4
Eu Ivd Annex 2 List B
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Expired / Withdrawn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 IV (excluding sections 4, 6) | HL2156856-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ACCU-ANSWER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| ACCU-ANSWER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| ACCU-ANSWER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| ACCU-ANSWER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| ACCU-ANSWER | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |