REAG-RED Panoptic 1000 ml
by REAGENS Fejlesztő, Gyártó és Kereskedelmi Kft.
Ref 31016Model REAG-RED Panoptic
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 | Number599654731RREDUR 05996547310168 | Date25 May 2022 | 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- Withdrawn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
- REAG-RED Panoptic
- Model / Reference
- REAG-RED Panoptic, 31016
- Primary DI / UDI-DI
- 05996547310168
- Basic UDI-DI
- 599654731RREDUR
- EMDN Code
- W0103010399 Haematology stains for microscopy - other
- Device Class
- Class A
- EU market of registration
- Hungary
Manufacturer details
- EUDAMED SRN
- HU-MF-000019161
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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