Tissue-Tek Prisma
Ref 6172Model Prisma-P-ED
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 | Number49464336172UB 04946433600614 | Date11 Nov 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- Withdrawn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
- Tissue-Tek Prisma Plus
- Model / Reference
- Prisma-P-ED, 6172
- Primary DI / UDI-DI
- 04946433600614
- Basic UDI-DI
- 49464336172UB
- EMDN Code
- W0202059002 Automated slide stainers
- Device Class
- Class A
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- JP-MF-000022209
- Authorised representative
- Sakura Finetek Europe B.V. NL-AR-000007853
Other devices from Sakura Seiki 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
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No