Identity
- Trade Name
- Histo-Tek EUDAMEDHisto-Tek® VP1™ FDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- Histo-Tek VP1 EUDAMEDVacuum Infiltration Processor FDA UDI
- Model / Reference
- VP1 EUDAMED1700 EUDAMEDFDA UDI
- Description
- Vacuum Infiltration Processor FDA UDI
Identifiers
- Catalog Number
- 1700 FDA UDI
- Primary DI / UDI-DI
- 04946433600485 EUDAMEDFDA UDI
- Basic UDI-DI
- 49464331700TD EUDAMED
- FDA Product Code
- IEO FDA UDI
- EMDN Code
- W0202059010 TISSUE PROCESSORS EUDAMED
- GMDN Term
- Tissue processor IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3875 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
Histo-Tek 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 | 49464331700TD | 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 25abc5e3-3b0a-45bb-a2ab-906e98b55b31 61 fields · synced Jun 19, 2026
- FDA UDI ea07207c-3cfb-4a5e-a1fa-35f03d480778 35 fields · synced May 30, 2026