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Real-time PCR System
EUDAMEDFDA UDIClass A (EU MDR)
Ref STC-96AModel STC-96A PLUS, STC-96A
Identity
- Trade Name
- Real-time PCR System EUDAMEDFDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification instrument IVD, manual FDA UDI
- Device Name
- Real-time PCR System EUDAMED
- Model / Reference
- STC-96A PLUS, STC-96A EUDAMEDSTC-96A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973342002473 EUDAMEDFDA UDI
- Basic UDI-DI
- 697334200STC96AHW EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification instrument IVD, manual FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 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
Real-time PCR System by Jiangsu Bioperfectus Technologies 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 | 697334200STC96AHW | 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 6d5c5bb0-bce1-4c60-b704-8caca39a80d1 61 fields · synced Jul 17, 2026
- FDA UDI 3a93905e-646b-4120-95a1-64008ff077a9 32 fields · synced May 30, 2026