Identity
- Trade Name
- iSWAB-Discovery EUDAMEDMawi DNA Technologies FDA UDI
- Generic Name
- Molecular grade buffered sample diluent IVD FDA UDI
- Device Name
- iSWAB-Discovery Human DNA Collection Device EUDAMEDiSWAB-Discovery Human DNA Collection Kit 400 ul FDA UDI
- Model / Reference
- ISWAB-DSC EUDAMEDFDA UDI
- Description
- iSWAB-Discovery Human DNA Collection Kit 400 ul FDA UDI
Identifiers
- Catalog Number
- ISWAB-DSC FDA UDI
- Primary DI / UDI-DI
- 00850040712049 EUDAMEDFDA UDI
- Basic UDI-DI
- 850040712001ISWAB-DSC4W EUDAMED
- FDA Product Code
- NNL 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-Discovery 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-DSC4W | 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 59aa96dd-0ba7-48f2-98d2-7c6737e06f04 61 fields · synced Jul 13, 2026
- FDA UDI b7122342-1d49-4b5f-8dda-a7a8bb50d821 36 fields · synced May 30, 2026