Starrsed Disinfectant
by RR Mechatronics Manufacturing BV Netherlands EUDAMEDGUDID
Ref QRR010947Model Starrsed Disinfectant Product code GKBEMDN W0103010105
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR EUDAMED | Number8719189137XR4TCPWB | Date28 Aug 2025 | StatusActive |
| United States | GUDID listing GUDID | Number08719189137231 | Date25 Jul 2023 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Generic Name
- Buffered wash solution IVD
- Model / Reference
- Starrsed Disinfectant, QRR010947
- Primary DI / UDI-DI
- 08719189137231
- Basic UDI-DI
- 8719189137XR4TCPWB
- Direct Marketing DI
- 08719189137231
- FDA Product Code
- GKB
- EMDN Code
- W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
- GMDN Term
- Buffered wash solution IVD
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 864.5800
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Liquid Chemical
- MRI Safety
- MR Safe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class A | Class I |
| Sterile | No | Yes |
Manufacturer details
- EUDAMED SRN
- NL-MF-000023105
Other devices from RR Mechatronics Manufacturing BV
Properties & raw data
Show properties, registry sources and raw records
Other properties (17)
- Implantable: No
- Contains Latex: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 41668fdc-d44c-4208-910e-6bb9569f69d7
- FDA UDI 20359464-3625-48ec-924d-50a01a8bca7d