Macro & Micro-Test General DNA/RNA Kit
by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. 8 variants
Ref HWTS-3019-8Model Type Ⅰ: 50 tests/ kit
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697484936W0105900101HP 06974849367843 | Date29 Nov 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Macro & Micro-Test Viral DNA/RNA Kit
- Model / Reference
- Type Ⅰ: 50 tests/ kit, HWTS-3019-8
- Primary DI / UDI-DI
- 06974849367843
- Basic UDI-DI
- 697484936W0105900101HP
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012807
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No