eNAT molecular collection and preservation medium
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- eNAT EUDAMED
- Device Name
- 2mL eNAT MOLECULAR COLLECTION & PRESERVATION MEDIUM EUDAMED2mL eNAT MEDIUM + REGULAR FLOQSwab + PASTEUR PIPET EUDAMEDeNAT EUDAMED2 ML PRESERVATION MEDIUM FOR NUCLEIC ACIDS MINITIP FL. APPLIC. EUDAMED
- Model / Reference
- 6U072S EUDAMED6U005S.Q EUDAMED6E101S EUDAMED606CS01M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 58053326009681 EUDAMED38053326001797 EUDAMED08053326011672 EUDAMED18053326001632 EUDAMED
- Basic UDI-DI
- B-58053326009681 EUDAMEDB-38053326001797 EUDAMED80533260CD0150AM00294 EUDAMEDB-18053326001632 EUDAMED
- 510(k) Number
- K201849 FDA 510(k)
- FDA Product Code
- QBD FDA 510(k)
- EMDN Code
- W050301020101 SAMPLES ANALYSES, PLASTIC TUBES WITH ADDITIVES EUDAMEDA1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMEDClass IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2950 FDA 510(k)
- Regulation Number
- 866.2950 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Administering Medicine
No
Measuring Function
No
Surgical Instrument
No
New Device
No
Incorporates Medicinal Product
No
eNAT molecular collection and preservation medium is a microbial nucleic acid storage and stabilization device designed to collect, transport, and preserve microbial specimens for nucleic acid testing. It maintains the integrity of genetic material from collection through laboratory processing.
Supplied as a non-sterile, single-use medium, it is intended for use in clinical microbiology laboratories. The device is not MRI safety assessed and should be stored according to manufacturer specifications. It holds FDA 510(k) clearance (K201849) and complies with IVDD, IVDR, and MDD regulatory frameworks.
Frequently asked questions
What is the primary function of the eNAT molecular collection and preservation medium?
The device is designed to collect, transport, and preserve microbial specimens by stabilizing nucleic acids, ensuring the genetic material remains intact from the point of collection through to laboratory analysis for microbiological testing.
Is the eNAT molecular collection and preservation medium sterile or single-use?
The device is supplied as a non-sterile, single-use medium, meaning it is intended for one-time use and is not provided in a sterile condition.
What regulatory clearances and classifications apply to the eNAT molecular collection and preservation medium?
The device has received FDA 510(k) clearance under K201849, is classified as a Class 2 device, and complies with IVDD, IVDR, and MDD regulatory requirements for in vitro diagnostic medical devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
IVDR
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | IVDR | — | Class II | Active |
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201849 | Class II | Active |
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Manufacturer
- Manufacturer
- Copan Italia Spa
Sources (5)
- FDA 510(k) K201849 24 fields · synced Sep 18, 2026
- EUDAMED b8c04af9-c208-404a-8571-ec6f5d936913 61 fields · synced Jul 13, 2026
- EUDAMED fa7b808e-2300-408f-9484-e0d7f2bd44fd 61 fields · synced Jul 18, 2026
- EUDAMED 1cf4d11b-eee3-4f2a-969c-cf7cf789e277 61 fields · synced Jul 21, 2026
- EUDAMED 6d43b198-969b-47c7-ad10-4827da3c252e 61 fields · synced Sep 17, 2026