Identity
- Device Name
- abSEQ™ Sequencing Set SE100 EUDAMED
- Model / Reference
- 302011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885019711053 EUDAMED08885019711046 EUDAMED
- Basic UDI-DI
- 888501971302011U6 EUDAMED
- EMDN Code
- W0105900103 SUPPLEMENTAL NA REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
abSEQ™ Sequencing Set SE100 by AITbiotech Pte Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 888501971302011U6 | Class A | Active |
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Manufacturer
- Manufacturer
- AITbiotech Pte Ltd
- EUDAMED SRN
- SG-MF-000003510
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 45f34a42-e29b-4c7e-83f7-14463edabb31 61 fields · synced Jul 30, 2026
- EUDAMED f3a1571f-8e64-49a3-b79e-3dccad740ced 61 fields · synced May 17, 2026