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Tissue-Tek
EUDAMEDClass A (EU MDR)
Ref 5113Model TEC 6-CM-E2Ref 5112Model TEC 6-EM-E2Ref 4742Model Film-E2
Identity
- Trade Name
- Tissue-Tek EUDAMEDTissue-Tek Film EUDAMED
- Device Name
- Tissue-Tek TEC 6 Cryo Module EUDAMEDTissue-Tek TEC 6 Embedding Module EUDAMEDTissue-Tek Film EUDAMED
- Model / Reference
- TEC 6-CM-E2 EUDAMED5113 EUDAMEDTEC 6-EM-E2 EUDAMED5112 EUDAMEDFilm-E2 EUDAMED4742 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04946433600607 EUDAMED04946433600591 EUDAMED04946433600638 EUDAMED
- Basic UDI-DI
- 49464335113TL EUDAMED49464335112TJ EUDAMED49464334742UJ EUDAMED
- EMDN Code
- W0202059012 COOLING PARAFFIN PLATES EUDAMEDW0202059004 TISSUE EMBEDDING PROCESSORS EUDAMEDW0202059008 AUTOMATED COVERSLIPPERS 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
Tissue-Tek by Sakura Seiki Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 49464335113TL | 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 (3)
- EUDAMED c98adab5-1c65-45c0-b749-4ecb9ba48628 61 fields · synced Jul 20, 2026
- EUDAMED de22f52e-24e6-4f45-b10a-2695acd85822 61 fields · synced May 17, 2026
- EUDAMED d3ea9a9e-30e4-4dfe-8a84-0f3162013fdb 61 fields · synced May 18, 2026