EU Manufacturer
๐จ๐ณ China
Active
Changsha Sinocare Inc.
SRN: CN-MF-000012244
ยท
No.265 Guyuan Road, Hi-tech Zone, 410205 Changsha, China
Basic UDI-DIs
67
Total Devices
68
On Market
68
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
19
Basic Information
- Address
- No.265 Guyuan Road, Hi-tech Zone, 410205 Changsha, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
63
Eu Mdr
3
Eu Ivdr
1
Classification
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Eu Ivd General
29
Eu Ivd Annex 2 List B
20
Eu Ivd Self Testing
14
Eu Md Class 2b
2
Eu Md Class 1
1
Eu Ivd Class A
1
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 060250 0017 | TรV SรD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | No. V1 060250 0017 | TรV SรD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | No.V1 0602500017 | TรV SรD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | No. V1060250 0017 | TรV SรD Product Service GmbH | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 19 countries across Europe.
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Safe AQ Smart | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| ACTIVATED PARTIAL THROMBOPLASTIN TIME - RT & POC | 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 |
| BETA2-MICROGLOBULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| BILE ACIDS | EU IVDD | Eu Ivd General | On Market | 0 |
| BLOOD GLUCOSE METERS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BLOOD GLUCOSE METERS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BLOOD GLUCOSE METERS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| BLOOD TEST STRIPS CONTROLS | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Blood Glucose Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Blood Glucose Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| C-REACTIVE PROTEIN - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| C-REACTIVE PROTEIN - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| CHLORIDE | EU IVDD | Eu Ivd General | On Market | 0 |
| CHOLESTEROL | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATINE KINASE ISOENZYMES | EU IVDD | Eu Ivd General | On Market | 0 |
| CREATININE | EU IVDD | Eu Ivd General | On Market | 0 |
| D-DIMER | EU IVDD | Eu Ivd General | On Market | 0 |
| ELECTROLYTES - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE | EU MDR | Eu Md Class 1 | On Market | 0 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GLUCOSE TEST STRIPS | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) | EU IVDD | Eu Ivd General | On Market | 0 |
| GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) | EU IVDD | Eu Ivd General | On Market | 0 |
| GlucoMenยฎ iCan | EU MDR | Eu Md Class 2b | On Market | 0 |
| HEART-TYPE FATTY ACID BINDING PROTEIN | EU IVDD | Eu Ivd General | On Market | 0 |
| HOMOCYSTEINE | EU IVDD | Eu Ivd General | On Market | 0 |
| IMMUNOGLOBULIN M | EU IVDD | Eu Ivd General | On Market | 0 |
| LACTATE DEHYDROGENASE ISOENZYMES | EU IVDD | Eu Ivd General | On Market | 0 |
| LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE PARAMETER BLOOD TEST | EU IVDD | Eu Ivd General | On Market | 0 |
| NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2) | EU IVDD | Eu Ivd General | On Market | 0 |
| PEPSINOGEN | EU IVDD | Eu Ivd General | On Market | 0 |
| PROCALCITONIN | EU IVDD | Eu Ivd General | On Market | 0 |
| PROTHROMBIN TIME RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| RHEUMATOID FACTORS | EU IVDD | Eu Ivd General | On Market | 0 |
| SPECIFIC PROTEINS - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| Safe AQ Smart | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Safe AQ UG | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |