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Tissue-Tek Prisma [EN]
EUDAMEDClass A (EU MDR)
Ref 6173Model Prisma-P-ESRef 6172Model Prisma-P-ED
Identity
- Trade Name
- Tissue-Tek Prisma [EN] EUDAMEDTissue-Tek Prisma EUDAMED
- Device Name
- Tissue-Tek Prisma Plus EUDAMED
- Model / Reference
- Prisma-P-ES EUDAMED6173 EUDAMEDPrisma-P-ED EUDAMED6172 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04946433600621 EUDAMED04946433600614 EUDAMED
- Basic UDI-DI
- 49464336173UD EUDAMED49464336172UB EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Microscope slide stainer IVD
Tissue-Tek Prisma [EN] by Sakura Seiki Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 49464336173UD | Class A | Active |
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Manufacturer
- Manufacturer
- Sakura Seiki Co., Ltd.
- EUDAMED SRN
- JP-MF-000022209
- Authorised Representative
- Sakura Finetek Europe B.V. NL-AR-000007853
Sources (2)
- EUDAMED 070988c8-789a-48b5-bd5c-75d6bd4c2c8f 61 fields · synced Sep 17, 2026
- EUDAMED b60c8355-0a91-46ee-94ca-7d4490201b55 61 fields · synced May 18, 2026