Identity
- Trade Name
- PS-10 EUDAMEDSample Preparation System PS-10 FDA UDI
- Generic Name
- Pipetting system IVD FDA UDI
- Device Name
- Sample Preparation System PS-10 EUDAMEDThe Sample Preparation System PS-10 is a fully automated, user-configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers. FDA UDI
- Model / Reference
- BQ716341 EUDAMEDPS-10 FDA UDI
- Description
- The Sample Preparation System PS-10 is a fully automated, user-configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562501908 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562PS-104R EUDAMED
- FDA Product Code
- PER FDA UDI
- EMDN Code
- W02020499 FLOW CYTOMETRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Pipetting system IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2750 FDA UDI
- Market of Registration
- Germany 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
Ps-10 by Sysmex Corporation — 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 | 4987562PS-104R | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (2)
- EUDAMED 74769385-7acc-41ae-ad2c-30d55ce160c3 61 fields · synced Jun 18, 2026
- FDA UDI 8df528c8-052f-4a71-818a-f188724f94d3 34 fields · synced May 25, 2026