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Biobase
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref BK-ASP96Model BK-ASP48，BK-ASP48P，BK-ASP96, etc.
Identity
- Trade Name
- Automated Liquid Handler EUDAMEDBIOBASE FDA UDI
- Generic Name
- Electronic pipette FDA UDI
- Device Name
- Automated Liquid Handler EUDAMED
- Model / Reference
- BK-ASP96 EUDAMEDFDA UDIBK-ASP48，BK-ASP48P，BK-ASP96, etc. EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936895301356 EUDAMEDFDA UDI
- Basic UDI-DI
- 6936895BS01329 EUDAMED
- FDA Product Code
- JQW FDA UDI
- EMDN Code
- W02060102 AUTOMATED SAMPLE TRANSPORT SYSTEMS EUDAMED
- GMDN Term
- Electronic pipette 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electronic pipette
Biobase by Biobase Biodustry(Shandong)Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electronic pipette.
- Procleix Xpress® System — Grifols Diagnostic Solutions Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong)Co., Ltd.
Sources (2)
- FDA UDI a8655cff-5d6a-4fcf-a8b4-751807f20c75 32 fields · synced Jul 21, 2026
- EUDAMED d8452c50-1680-4fea-912c-ec6f43b8c658 61 fields · synced Jul 21, 2026