EU Manufacturer
🇨🇳 China
Active
Abon Biopharm(Hangzhou) Co., Ltd
SRN: CN-MF-000009171
·
198# 12th Street East, Hangzhou Economic & Technological Development Area, 310018 Hangzhou, China
Basic UDI-DIs
123
Total Devices
123
On Market
123
Off Market
0
Certificates
5
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- 198# 12th Street East, Hangzhou Economic & Technological Development Area, 310018 Hangzhou, China
- [email protected]
- Phone
- +86 571 81638052
Regulatory Overview
Regulation
Loading...
Eu Ivdd
123
Classification
Loading...
Eu Ivd General
118
Eu Ivd Annex 2 List A
3
Eu Ivd Annex 2 List B
2
Device Types
Loading...
Certificate Health
Total
5
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
5
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No. V1 058228 0009 | TÜV SÜD Product Service GmbH | Jan 16, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | No. 11 0497 QS/NB | INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 | May 26, 2025 | |||
| IVDD Annex IV Section 4 | No. 11 0498 CN/NB | INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390 | May 26, 2025 | |||
| IVDD Annex IV Section 4 | N°20317 | GMED SAS | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | N°19820 | GMED SAS | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| AMPHETAMINES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| AMPHETAMINES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| AMPHETAMINES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| AMPHETAMINES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| BACTERIOLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| BARBITURATES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| BENZODIAZEPINES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| BENZODIAZEPINES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| BENZODIAZEPINES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| CANNABINOIDS - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| CANNABINOIDS - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| CHLAMYDIA AG - RT & POC | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| COCAINE + COCAINE METABOLITES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| COCAINE + COCAINE METABOLITES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| COCAINE + COCAINE METABOLITES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| COCAINE + COCAINE METABOLITES - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| H. PYLORI - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| H. PYLORI - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| H. PYLORI - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| H. PYLORI - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| H. PYLORI ANTIGEN DETECTION | EU IVDD | Eu Ivd General | On Market | 0 |
| HBSAG - RT & POC | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| HCG - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| HCG - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| HCG - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| HCG - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| HCG - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| HCG - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| HCG - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| HCV ANTIBODY -RT & POC | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| HIV 1 / 2 - RT & POC | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INFLUENZA A AND /OR B - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |