Identity
- Device Name
- Tissue-Tek® Coverslipping Film EUDAMED
- Model / Reference
- 4770-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560133244130 EUDAMED
- Basic UDI-DI
- 456013324W05039002000014C EUDAMED
- EMDN Code
- W0503900202 MICROSCOPE SLIDES COVERSLIP 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Tissue-Tek® Coverslipping Film by Sakura Finetek Japan 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 | 456013324W05039002000014C | Class A | Active |
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Manufacturer
- Manufacturer
- Sakura Finetek Japan Co., Ltd.
- EUDAMED SRN
- JP-MF-000022210
- Authorised Representative
- Sakura Finetek Europe B.V. NL-AR-000007853
Sources (1)
- EUDAMED e83abfd7-ff3a-4867-9763-7daf4c3e1f4a 61 fields · synced Jun 19, 2026