Sample Diluent
by Nanjing RealMind Biotech Co., Ltd. 5 variants
Ref D011 1x20mL/bottleModel Model: D001,D002,D003,D004,D005,D006,D007,D008,D009,D010,D011,D012
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 | Number6972719600003AT 06972719601615 | Date26 May 2025 | 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- Withdrawn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
- Sample Diluent
- Model / Reference
- Model: D001, D002, D003, D004, D005, D006, D007, D008, D009, D010, D011, D012, D011 1x20mL/bottle
- Primary DI / UDI-DI
- 06972719601615
- Basic UDI-DI
- 6972719600003AT
- EMDN Code
- W0599 IVD general use consumable devices - other
- Device Class
- Class A
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000024838
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Nanjing RealMind Biotech Co., Ltd.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No