Identity
- Trade Name
- Tissue-Tek EUDAMED
- Device Name
- Tissue-Tek Glas g2 EUDAMED
- Model / Reference
- Glas g2-E2 EUDAMED6502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04946433600645 EUDAMED
- Basic UDI-DI
- 49464336502UA EUDAMED
- EMDN Code
- W0202059008 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 | 49464336502UA | 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 (1)
- EUDAMED 062f217b-9290-49b3-8cb3-9b452e6cd301 61 fields · synced Jun 19, 2026