Identity
- Trade Name
- Elisa Microplate Reader EUDAMEDBIOBASE FDA UDI
- Generic Name
- Microplate reader IVD, automated/semi-automated FDA UDI
- Device Name
- Elisa Microplate Reader EUDAMED
- Model / Reference
- BS005 EUDAMEDBK-EL10DA EUDAMEDBK-EL10A FDA UDIBK-EL10C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936895300212 EUDAMEDFDA UDI06936895300236 EUDAMEDFDA UDI06978527670119 EUDAMED
- Basic UDI-DI
- 6936895BS0052A EUDAMED
- FDA Product Code
- JJQ FDA UDI
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
- GMDN Term
- Microplate reader IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2300 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
Elisa Microplate Reader by Biobase Biodustry(Shandong) 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 | 6936895BS0052A | 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 (7)
- EUDAMED 902074b2-88d2-47c7-b2a6-0bd642a8f134 61 fields · synced Oct 6, 2026
- EUDAMED dbf47224-8100-42c9-bf45-695073d83a59 61 fields · synced May 17, 2026
- FDA UDI 327dba37-eebd-499a-977a-7ba88dd3e366 32 fields · synced May 30, 2026
- FDA UDI 3407ca3f-e758-4672-a90d-17aa8c59a159 32 fields · synced May 30, 2026
- EUDAMED 593f0cc8-7dc9-49a5-a0c2-fdca7b2335c5 61 fields · synced Jun 20, 2026
- EUDAMED e433ca76-51a4-4612-87dd-4ebfa1a116a0 61 fields · synced Jul 9, 2026
- EUDAMED 78bbf249-091b-458e-9f62-3a342be50d76 61 fields · synced Aug 2, 2026