Identity
- Trade Name
- Tissue-Tek AutoTEC EUDAMEDTissue-Tek AutoTEC® a120 FDA UDI
- Generic Name
- Tissue embedding unit IVD FDA UDI
- Device Name
- Tissue-Tek AutoTEC a120 EUDAMEDAutomated Embedder FDA UDI
- Model / Reference
- AutoTEC a120 EUDAMED7090 EUDAMEDFDA UDI
- Description
- Automated Embedder FDA UDI
Identifiers
- Catalog Number
- 7090 FDA UDI
- Primary DI / UDI-DI
- 04946433600362 EUDAMEDFDA UDI
- Basic UDI-DI
- 49464337090UF EUDAMED
- FDA Product Code
- IDW FDA UDI
- EMDN Code
- W0202059004 TISSUE EMBEDDING PROCESSORS EUDAMED
- GMDN Term
- Tissue embedding unit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Tissue-Tek AutoTEC by Sakura Seiki Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 49464337090UF | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 1385e186-4c19-410a-a843-a5aa2fdf435a 61 fields · synced Jul 31, 2026
- FDA UDI e860bdae-d0f9-487c-9fd8-cfe7df478b50 35 fields · synced May 30, 2026