Identity
- Trade Name
- Automated Sample Processing System EUDAMEDBIOBASE FDA UDI
- Generic Name
- Electronic pipette FDA UDI
- Device Name
- Automated Sample Processing System EUDAMED
- Model / Reference
- BS004 EUDAMEDBKPR32 FDA UDIBKPR48 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936895300175 EUDAMEDFDA UDI06936895300182 EUDAMEDFDA UDI
- Basic UDI-DI
- 6936895BS00428 EUDAMED
- FDA Product Code
- JQW FDA UDI
- EMDN Code
- W02069001 AUTOSAMPLERS 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
Automated Sample Processing System by Biobase Biodustry(Shandong) Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 6936895BS00428 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (6)
- EUDAMED f91c2936-2ddc-473a-a2d9-e38b3c2e24aa 61 fields · synced Jul 14, 2026
- EUDAMED ac72c022-1c85-4d45-bb48-36db3ec54e04 61 fields · synced May 19, 2026
- FDA UDI c6fb77c8-7ee9-4f1c-b9a7-50c700eb95ed 32 fields · synced May 30, 2026
- FDA UDI d86b2a51-99a9-4f79-9bac-2c241773c032 32 fields · synced May 30, 2026
- EUDAMED 7e3c8f79-0771-4ca0-96f3-518ed2b703a7 61 fields · synced Jun 19, 2026
- EUDAMED d12cc00e-3fce-4784-9a65-f922354a9940 61 fields · synced Jul 14, 2026