Blue Collect
by FertiPro
Ref IB_CD01
Blue Collect (IB_CD01) is a Class A device made by FertiPro, registered in EUDAMED on 28 Aug 2023 (Basic UDI-DI 5411967CD1B3), active as of 22 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number5411967CD1B3 05411967003747 | Date28 Aug 2023 | StatusActive |
Official records
- EUDAMED public site 5411967CD1B3
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / reference
- IB_CD01
- Primary DI / UDI-DI
- 05411967003747
- Basic UDI-DI
- 5411967CD1B3
- Direct marketing DI
- 05411967003747
- EMDN code
- W05019002 Saliva collection devices
- Device class
- Class A
- EU registration type
- Standard device
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- BE-MF-000000313
Similar devices in this category
Other devices filed under SALIVA COLLECTION DEVICES.
- Saliva DNA Storage Tube CWX021S by Jiangsu CoWin Biotech Co., Ltd.
- SaliCap Set RE69985 by IBL INTERNATIONAL GMBH
- OMNIgene ORAL OME-505.005 by DNA Genotek Inc
- Master Diagnóstica MAD-000230QK/N by VITRO, S.A.
- Salivette® 51.1534 by Sarstedt Aktiengesellschaft & Co.KG
- DNA/RNA Shield SafeCollect Saliva Collection Kit R1211-E by Zymo Research Corp.
- ORAgene Dx OGD-675 by DNA Genotek Inc
- Salivette® Cortisol, code blue 51.1534.500 by Sarstedt Aktiengesellschaft & Co.KG
- Disposable specimen collection system QI-7.5.8-02 by Weihai Sunway Medical Technology Co.,Ltd
- Oral Fluid Collection Tube STGJ0201 by Suzhou Shengtian Biotechnology Co., Ltd.