EU Manufacturer
🇨🇳 China
Active
Shenzhen New Industries Biomedical Engineering Co., Ltd.
SRN: CN-MF-000005655
·
Jinxiu East Road No.23, 518122 Shenzhen, China
Basic UDI-DIs
48
Total Devices
50
On Market
50
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Jinxiu East Road No.23, 518122 Shenzhen, China
- [email protected]
- Website
- www.snibe.com
Regulatory Overview
Regulation
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Eu Ivdd
32
Eu Ivdr
16
Classification
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Eu Ivd General
31
Eu Ivd Class A
16
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Expired / Withdrawn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) | No. V1 105113 0002 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| MAGLUMI A Ⅰ(CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Troponin I (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI 800 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI A Ⅱ(CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Anti-HAV (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Anti-M2-3E IgG (CLIA | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Anti-SS-A IgG (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Anti-nRNP/Sm IgG (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI C IV (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI CSA (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Chagas (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI FK 506 (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI FT3 (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI FT4 (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI GAD65 (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI GH (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI HA (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI HAV IgM (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI HCG/β-HCG (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Light Check | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI PG I (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI PRG (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI PRL (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Pepsinogen II (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Preaccu for Prenatal Screening | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Reaction Cup | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Reaction Module | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI S-100 (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Sample Diluent | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Sample Extraction Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Sample Release Agent | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Starter 1+2 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Starter 1+2 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI System Tubing Cleaning Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI T3 (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI T4 (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI TG (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI TGA (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI TMA (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI TPA-snibe (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI Tip | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Wash Concentrate | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Wash Concentrate | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI Waste Bag | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI X3 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI X6 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI X8 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| MAGLUMI f-PSA (CLIA) | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| MAGLUMI free Estriol (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |
| MAGLUMI β2-MG (CLIA) | EU IVDD | Eu Ivd General | On Market | 0 |