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iSWAB
EUDAMEDFDA UDIClass A (EU MDR)
Ref ISR2-T-1200-RRef ISC-T-1200-RRef ISF-T-DSCRef ISD-T-1200-RRef ISM-T-EL-RRef iSWAB-MBF-1200Ref ISWAB-CELLS-1200Ref ISM-T-ELRef ISF-T-250
Identity
- Trade Name
- iSWAB EUDAMEDiSWAB-Discovery Human DNA Collection Tube EUDAMEDMawi DNA Technologies FDA UDI
- Generic Name
- General specimen container IVD, additive/medium FDA UDIMolecular grade buffered sample diluent IVD FDA UDI
- Device Name
- iSWAB RNA v2 Collection Device EUDAMEDiSWAB Cells Collection Device EUDAMEDiSWAB-Discovery Human DNA Collection Device EUDAMEDiSWAB DNA Collection Device EUDAMEDiSWAB Microbiome Collection Device EUDAMEDiSWAB-ID Human DNA Collection Device EUDAMEDiSWAB Cells Collection Kit 1.0 ml FDA UDIiSWAB Microbiome Collection Kit (with FecesCatcher) 1.0 ml FDA UDIiSWAB-ID Human DNA Collection Tube 400 ul FDA UDIiSWAB Microbiome EL Collection Tube 800 ul FDA UDIiSWAB-Discovery Human DNA Collection Tube 400 ul FDA UDI
- Model / Reference
- ISR2-T-1200-R EUDAMEDISC-T-1200-R EUDAMEDISF-T-DSC EUDAMEDFDA UDIISD-T-1200-R EUDAMEDISM-T-EL-R EUDAMEDISWAB-CELLS-1200 EUDAMEDFDA UDIiSWAB-MBF-1200 EUDAMEDFDA UDIISF-T-250 EUDAMEDFDA UDIISM-T-EL EUDAMEDFDA UDI
- Description
- iSWAB Cells Collection Kit 1.0 ml FDA UDIiSWAB Microbiome Collection Kit (with FecesCatcher) 1.0 ml FDA UDIiSWAB-ID Human DNA Collection Tube 400 ul FDA UDIiSWAB Microbiome EL Collection Tube 800 ul FDA UDIiSWAB-Discovery Human DNA Collection Tube 400 ul FDA UDI
Identifiers
- Catalog Number
- ISWAB-CELLS-1200 FDA UDIiSWAB-MBF-1200 FDA UDIISF-T-250 FDA UDIISM-T-EL FDA UDIISF-T-DSC FDA UDI
- Primary DI / UDI-DI
- 10850040712091 EUDAMED10850040712152 EUDAMED00850040712070 EUDAMEDFDA UDI10850040712015 EUDAMED20850040712135 EUDAMED00850040712148 EUDAMEDFDA UDI00850040712117 EUDAMEDFDA UDI00850040712131 EUDAMEDFDA UDI20850040712067 EUDAMED00850040712063 FDA UDI
- Basic UDI-DI
- 850040712001ISWAB-RNA6H EUDAMED850040712001ISWAB-CELLSQU EUDAMED850040712001ISWAB-DSC4W EUDAMED850040712001ISWAB-DNA4B EUDAMED850040712001iSWAB-MB3J EUDAMED850040712ISWAB-IDNR EUDAMED
- Direct Marketing DI
- 10850040712152 EUDAMED10850040712015 EUDAMED20850040712135 EUDAMED00850040712117 EUDAMED20850040712067 EUDAMED
- FDA Product Code
- JJH FDA UDIPPM FDA UDINNL FDA UDI
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, additive/medium FDA UDIMolecular grade buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI864.4010 FDA UDI864.3250 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
EUDAMEDEUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDIFDA 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 (14)
- EUDAMED 7e379472-769e-458b-a2f8-efd0b5034816 61 fields · synced Jul 30, 2026
- EUDAMED 504fae72-e757-42ce-925e-2b2658a7fe26 61 fields · synced May 17, 2026
- EUDAMED 22759a06-86d4-41d6-83c7-ddcfdcfe68eb 61 fields · synced May 17, 2026
- EUDAMED 6b5bfe0c-a8b7-45d8-a65a-91bebe37a2fb 61 fields · synced May 18, 2026
- EUDAMED c460bdc8-ed32-4455-8b53-f186d8fdc834 61 fields · synced May 18, 2026
- FDA UDI bda59e40-f6a4-4973-b500-8a7a961b7ab9 36 fields · synced May 30, 2026
- FDA UDI edfb980c-352c-4e3b-9ee8-40ded3794a9d 35 fields · synced May 30, 2026
- FDA UDI 92fc6d7f-4d08-4bb3-8de2-1fcd88eb3a5c 36 fields · synced May 30, 2026
- FDA UDI 9f6fc1ae-f6d3-4ed9-9a65-09a87db0124c 36 fields · synced May 30, 2026
- FDA UDI e32043db-409c-44a4-a78b-f9fe3ce3b7e5 36 fields · synced May 30, 2026
- EUDAMED 9ee6e578-d522-40e9-ba42-6923db3492a7 61 fields · synced Jul 10, 2026
- EUDAMED 1d53ce67-60e5-4e45-9838-425f0f5e7235 61 fields · synced Jul 10, 2026
- EUDAMED 074f2e16-0c19-4228-b5ac-98883ad60436 61 fields · synced Jul 25, 2026
- EUDAMED 943c56a6-b7bc-47c3-86ee-4f65613615e7 61 fields · synced Jul 30, 2026