abSEQ™ Sequencing Set SE100
Ref 302011
abSEQ™ Sequencing Set SE100 (302011) is a Class A device made by AITbiotech Pte Ltd, registered in EUDAMED on 6 Oct 2025 (Basic UDI-DI 888501971302011U6), active as of 25 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 | Number888501971302011U6 | Date6 Oct 2025 | StatusActive |
Official records
- EUDAMED public site 888501971302011U6
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- Withdrawn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
- Device name
- abSEQ™ Sequencing Set SE100
- Model / reference
- 302011
- Primary DI / UDI-DI
- 08885019711053, 08885019711046
- Basic UDI-DI
- 888501971302011U6
- EMDN code
- W0105900103 Supplemental na reagents
- Device class
- Class A
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- SG-MF-000003510
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
From the manufacturer
Manufacturer's product page: Ab SEQ Detail
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