EU Manufacturer
๐จ๐ณ China
Active
Maccura Biotechnology Co., Ltd.
SRN: CN-MF-000014618
ยท
Baichuan Road, Hi-tech Zone, 16#, , 611731 Chengdu, China
Basic UDI-DIs
1794
Total Devices
1799
On Market
1799
Off Market
0
Certificates
3
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Baichuan Road, Hi-tech Zone, 16#, , 611731 Chengdu, China
- [email protected]
- Phone
- +86 28 87826777
- Website
- www.maccura.com/en/
Regulatory Overview
Regulation
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Eu Ivdd
1752
Eu Ivdr
42
Classification
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Eu Ivd General
1612
Eu Ivd Annex 2 List B
112
Eu Ivd Class A
41
Eu Ivd Self Testing
28
Eu Ivd Class B
1
Device Types
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Certificate Health
Total
3
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
3
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 059892 0009 | TรV SรD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | No.V1 0598920009 | TรV SรD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex III Section 6 | 1434-IVDD-174/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd General | On Market | 0 |
| 5'-NUCLEOTIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| 5'-NUCLEOTIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| 5'-NUCLEOTIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| 5'-NUCLEOTIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| 5'-NUCLEOTIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| 5'-NUCLEOTIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| 5'-NUCLEOTIDASE | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| A1-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME | EU IVDD | Eu Ivd General | On Market | 0 |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME | EU IVDD | Eu Ivd General | On Market | 0 |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME | EU IVDD | Eu Ivd General | On Market | 0 |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME | EU IVDD | Eu Ivd General | On Market | 0 |
| ADRENOCORTIOTROPIC HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |
| ADRENOCORTIOTROPIC HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |
| ADRENOCORTIOTROPIC HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |
| ADRENOCORTIOTROPIC HORMONE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALANINE AMINO-TRANSFERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALANINE AMINO-TRANSFERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALANINE AMINO-TRANSFERASE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (CC) | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (CC) | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (CC) | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (IC) INCL. UALBUMIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (IC) INCL. UALBUMIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN (IC) INCL. UALBUMIN | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN INCL. UALBUMIN RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN INCL. UALBUMIN RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| ALBUMIN INCL. UALBUMIN RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| ALDOSTERONE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALDOSTERONE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALDOSTERONE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALDOSTERONE | EU IVDD | Eu Ivd General | On Market | 0 |
| ALKALINE PHOSPHATASE - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| ALKALINE PHOSPHATASE - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| ALKALINE PHOSPHATASE - TOTAL | EU IVDD | Eu Ivd General | On Market | 0 |
| ALPHAFETOPROTEIN | EU IVDD | Eu Ivd General | On Market | 0 |