Automatic Nucleic Acid Extraction System
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Automatic Nucleic Acid Extraction System EUDAMEDBIOBASE FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- Automatic Nucleic Acid Extraction System EUDAMED
- Model / Reference
- BS008 EUDAMEDBK-HS96A EUDAMEDFDA UDIBK-HS96B EUDAMEDFDA UDIBK-Auto HS96 FDA UDIBK-HS96 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936895300144 EUDAMEDFDA UDI06936895300137 EUDAMEDFDA UDI06936895301172 EUDAMEDFDA UDI06936895301189 EUDAMEDFDA UDI
- Basic UDI-DI
- 6936895BS0082G EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
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
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nucleic acid sample preparation instrument IVD
Automatic Nucleic Acid Extraction System by Biobase Biodustry(Shandong) Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6936895BS0082G | 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 (10)
- EUDAMED 8803ca5c-9c72-42f0-8180-6ef44d41352e 61 fields · synced Aug 4, 2026
- EUDAMED 6a8a1fd9-3875-4d33-952e-c125e01c86ee 61 fields · synced May 17, 2026
- FDA UDI 8cbadb85-e769-415a-a3f5-03636eccc2ef 32 fields · synced May 27, 2026
- FDA UDI 88ab1791-6fc1-4d23-bcd2-88e7117b60f3 32 fields · synced May 29, 2026
- FDA UDI 1fe1a0f8-160b-4bd1-bb6a-cb7d116f6b24 32 fields · synced May 30, 2026
- FDA UDI 33798635-b9b1-4abf-b686-a4a6a0ad8ae1 32 fields · synced May 30, 2026
- EUDAMED d51733f5-b94d-4e76-a62a-54b73877afac 61 fields · synced Jul 18, 2026
- EUDAMED 66d95f36-4788-42ca-a7d9-9757677f40a2 61 fields · synced Jul 19, 2026
- EUDAMED a9da003c-7e6d-4f4b-bafb-a8c39e015e02 61 fields · synced Jul 20, 2026
- EUDAMED a65c680a-864b-4221-86f5-43ce006ab829 61 fields · synced Aug 4, 2026