Authorized Representative
🇩🇪 Germany
Active
PureMDR GmbH
SRN: DE-AR-000007923
·
Eschersheimer Landstraße 42, 60322 Frankfurt am Main, Germany
Manufacturers
9
Devices
21
Certificates
1
PRRCs
1
Basic Information
- Address
- Eschersheimer Landstraße 42, 60322 Frankfurt am Main, Germany
- [email protected]
- Website
- https://www.purefda.com/
- Trade Register
- HRB 121793
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Hang Fai Optical Industrial Co. | 🇨🇳 China | CN-MF-000012864 |
| Ningbo Lvtang Biotechnology Co., Ltd. | 🇨🇳 China | CN-MF-000012878 |
| Hubei Yinfu Medical Products Co., Ltd. | 🇨🇳 China | CN-MF-000012872 |
| Jianxing shoe (Foshan) Co., Ltd | 🇨🇳 China | CN-MF-000015546 |
| Xiantao Yujie Protective Equipment Co., LTD. | 🇨🇳 China | CN-MF-000018116 |
| Xiantao Sanwei Medical Supplies Co.,LTD | 🇨🇳 China | CN-MF-000030322 |
| Zhuhai Gaoge Medical Technology Co.,Ltd. | 🇨🇳 China | CN-MF-000021349 |
| JINAN BABIO BIOTECHNOLOGY CO., LTD. | 🇨🇳 China | CN-MF-000012865 |
| Shanghai BioGerm Medical Technology Co., Ltd. | 🇨🇳 China | CN-MF-000018164 |
Manufacturers
Xiantao Yujie Protective Equipment Co., LTD.
Manufacturer
🇨🇳 China
Jianxing shoe (Foshan) Co., Ltd
Manufacturer
🇨🇳 China
Zhuhai Gaoge Medical Technology Co.,Ltd.
Manufacturer
🇨🇳 China
JINAN BABIO BIOTECHNOLOGY CO., LTD.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·12 Devices
Hubei Yinfu Medical Products Co., Ltd.
Manufacturer
🇨🇳 China
Hang Fai Optical Industrial Co.
Manufacturer
🇨🇳 China
Xiantao Sanwei Medical Supplies Co.,LTD
Manufacturer
🇨🇳 China
Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer
🇨🇳 China·9 Basic UDI-DIs·9 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Ningbo Lvtang Biotechnology Co., Ltd.
Manufacturer
🇨🇳 China
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-076/2022 | Shanghai BioGerm Medical Technology Co., Ltd. | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Devices
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
Disposable Sampling Swab
Device
EU MDR
·
Eu Md Class 1
·JINAN BABIO BIOTECHNOLOGY CO., LTD.·On the market
BioGerm SARS-CoV-2 Antigen Self Test
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market·32 countries
BioGerm SARS-CoV-2 Antigen Self Test
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market
BioGerm SARS-CoV-2 Antigen Self Test
Device
EU IVDD
·
Eu Ivd Self Testing
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market
Automatic Nucleic Acid Purification Instrument
Device
EU IVDR
·
Eu Ivd Class A
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)
Device
EU IVDD
·
Eu Ivd General
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market
Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd General
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market
Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd General
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market
Nucleic acid extraction and purification kit
Device
EU IVDR
·
Eu Ivd Class A
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market
Nucleic acid extraction and purification kit
Device
EU IVDR
·
Eu Ivd Class A
·Shanghai BioGerm Medical Technology Co., Ltd.·On the market