Identity
- Trade Name
- iSWAB EUDAMED
- Device Name
- iSWAB-Respiratory Tract Sample Collection Media-Extraction-Less Rack EUDAMED
- Model / Reference
- IRC-T-EL-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20850040712258 EUDAMED
- Basic UDI-DI
- 85004071220850040712258RC EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
iSWAB by Mawi DNA Technologies, LLC — 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 | 85004071220850040712258RC | Class A | Active |
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Manufacturer
- Manufacturer
- Mawi DNA Technologies, LLC
- EUDAMED SRN
- US-MF-000023207
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 3c36480c-b944-4dd0-88ac-52483dd7fd7a 61 fields · synced May 23, 2026