← Back to catalogue
Easy Amp Real-time Fluorescence Isothermal Detection System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Easy Amp Real-time Fluorescence Isothermal Detection System FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Model / Reference
- HWTS-1600S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974849369076 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
Easy Amp Real-time Fluorescence Isothermal Detection System by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class II — IVDR, FDA UDI — listed in FDA GUDID…
Similar devices
Also classified as Thermal cycler nucleic acid amplification analyser IVD, laboratory.
- FilmArray® 2.0 Instrument NGDS Configuration — BioFire Defense, LLC · Class II
- m2000 — Abbott Molecular · Class II
- FilmArray® 2.0 Instrument NGDS Configuration — BioFire Defense, LLC · Class II
- QuantStudio™ 7 Pro Dx Software, V3.0.0 — LIFE TECHNOLOGIES LIMITED · Class II
- COBAS®TaqMan® 48 Analyzer — Roche Molecular Systems, Inc. · Class I
- FilmArray® Torch Module — BioFire Diagnostics, LLC · Class II
- QLoci — LIFEOS GENOMICS CORPORATION · Class II
- GeneXpert Dx System — CEPHEID · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Sources (2)
- FDA UDI d0f13d70-6804-4ab6-88f8-5ab48bc255e7 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026