Identity
- Trade Name
- iSWAB EUDAMEDMawi DNA Technologies FDA UDI
- Generic Name
- Molecular grade buffered sample diluent IVD FDA UDI
- Device Name
- iSWAB RNA v2 Collection Device EUDAMEDiSWAB RNA v2 Collection Kit 1.0 ml FDA UDI
- Model / Reference
- ISWAB-RNA-v2 EUDAMEDFDA UDI
- Description
- iSWAB RNA v2 Collection Kit 1.0 ml FDA UDI
Identifiers
- Catalog Number
- ISWAB-RNA-v2 FDA UDI
- Primary DI / UDI-DI
- 00850040712087 EUDAMEDFDA UDI
- Basic UDI-DI
- 850040712001ISWAB-RNA6H EUDAMED
- FDA Product Code
- NNK FDA UDI
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Molecular grade buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
iSWAB by Mawi DNA Technologies, LLC — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 850040712001ISWAB-RNA6H | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Mawi DNA Technologies, LLC
- EUDAMED SRN
- US-MF-000023207
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 28d1975d-4fde-4d00-988c-5ce4a79024ef 61 fields · synced May 30, 2026
- FDA UDI 4fc3af5c-1b16-437d-86ec-59e51652cfd0 36 fields · synced May 29, 2026