Sample Collection and Release Reagent SCR-100
by Wuhan MGI Tech Co., Ltd. EUDAMED
Active
Ref 1000027693Model SCR-100
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697431813SCRSU | Date3 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Sample Collection and Release Reagent
- Model / Reference
- SCR-100, 1000027693
- Primary DI / UDI-DI
- 06974318130527
- Basic UDI-DI
- 697431813SCRSU
- Direct Marketing DI
- 06974318130527
- EMDN Code
- W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
- Device Class
- Class A
- Market of Registration
- Latvia
Manufacturer details
- EUDAMED SRN
- CN-MF-000018732
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Wuhan MGI Tech Co., Ltd.
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