Identity
- Trade Name
- SalivaGene® Swab Comfort EUDAMED
- Device Name
- SalivaGene® Swab Comfort EUDAMED
- Model / Reference
- 1035231100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05600236235235 EUDAMED
- Basic UDI-DI
- 5600236235AA007ED EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
SalivaGene® Swab Comfort by ALS Life Sciences Portugal, S.A. — 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 | 5600236235AA007ED | Class A | Active |
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Manufacturer
- Manufacturer
- ALS Life Sciences Portugal, S.A.
- EUDAMED SRN
- PT-MF-000034751
Sources (1)
- EUDAMED a9044892-33ca-47f6-9c3d-f29e2da12b33 61 fields · synced Jun 19, 2026