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Nucleic Acid Extraction System
EUDAMEDFDA UDIClass A (EU MDR)
Ref SSNP-3000AModel SSNP-2000B, SSSNP-3000A, SSNP-9600A,SMPE-960, SSNP-A6
Identity
- Trade Name
- Nucleic Acid Extraction System EUDAMEDFDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- Nucleic Acid Extraction System EUDAMED
- Model / Reference
- SSNP-2000B, SSSNP-3000A, SSNP-9600A,SMPE-960, SSNP-A6 EUDAMEDSSNP-3000A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973342000110 EUDAMEDFDA UDI
- Basic UDI-DI
- 697334200SSNPMP EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER 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
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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Nucleic Acid Extraction System by Jiangsu Bioperfectus Technologies 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 | 697334200SSNPMP | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED cfc14303-c3f9-42cd-bdf4-d478a639c2ee 61 fields · synced Jul 12, 2026
- FDA UDI 67886494-c8de-473b-aa29-e7956ec7faab 32 fields · synced May 30, 2026