Identity
- Trade Name
- iSWAB EUDAMEDMawi DNA Technologies FDA UDI
- Generic Name
- General specimen container IVD, additive/medium FDA UDI
- Device Name
- iSWAB Microbiome Collection Device EUDAMEDiSWAB Microbiome Collection Tube 1.0 ml FDA UDI
- Model / Reference
- ISM-T-1200 EUDAMEDFDA UDI
- Description
- iSWAB Microbiome Collection Tube 1.0 ml FDA UDI
Identifiers
- Catalog Number
- ISM-T-1200 FDA UDI
- Primary DI / UDI-DI
- 00850040712124 EUDAMEDFDA UDI
- Basic UDI-DI
- 850040712001iSWAB-MB3J EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 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
Yes
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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-MB3J | 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 4234d224-d388-4fda-8c07-9180316be0f9 61 fields · synced Jul 8, 2026
- FDA UDI 6397d1c4-3635-4eb0-9128-7641b1142bd6 36 fields · synced May 30, 2026