Automated Sample Processing System
by Biobase Biodustry(Shandong) Co., Ltd. China EUDAMEDGUDID
Ref BS004
Product code JQWEMDN W02069001
Overview
The Automated Sample Processing System (ASPS) is a cutting-edge medical device designed for streamlined sample processing, enhancing laboratory workflows and efficiency. Leveraging advanced technology, this device streamlines the collection, processing, and analysis of biological samples, providing accurate and reliable results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06936895300205 | Date4 Jul 2023 | StatusIn distribution |
| European Union | CE/IVDR EUDAMED | Number6936895BS00428 | Date25 Oct 2022 | StatusActive |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Automated Sample Processing System EUDAMEDBiobase GUDID
- Generic Name
- Electronic pipette
- Model / Reference
- BS004 EUDAMEDBKPR32P GUDID
- Primary DI / UDI-DI
- 06936895300205
- Basic UDI-DI
- 6936895BS00428
- FDA Product Code
- JQW
- EMDN Code
- W02069001 Autosamplers
- GMDN Term
- Electronic pipette
- Device Class
- Class A EUDAMEDClass I GUDID
- Regulation Number
- 862.2750
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | BS004 | BKPR32P |
| Device Class | Class A | Class I |
Manufacturer details
- EUDAMED SRN
- CN-MF-000025015
- Authorised representative
- Luxus Lebenswelt GmbH DE-AR-000005110
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Properties & raw data
Show properties, registry sources and raw records
Other properties (18)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
Sources (2)
- EUDAMED 9a0cb815-96e9-466b-8061-c1d788179d7a
- FDA UDI 32ebc233-bf54-4455-8e89-2da2d774e0bd