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E10 Nucleic Acid Extraction System
EUDAMEDFDA UDIClass A (EU MDR)
Ref 48031Model E10
Identity
- Trade Name
- E10 Nucleic Acid Extraction System EUDAMEDTARGETINGONE FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- E10 Nucleic Acid Extraction System EUDAMED
- Model / Reference
- E10 EUDAMED48031 EUDAMEDE10 Nucleic Acid Extraction System/E10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974689625141 EUDAMEDFDA UDI
- Basic UDI-DI
- 0697468962514B3 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
E10 Nucleic Acid Extraction System by TargetingOne Technology (Beijing) Corporation — 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 | 0697468962514B3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 559f0d71-07b8-4486-a5c5-1672b6f9d63b 61 fields · synced Jun 18, 2026
- FDA UDI 5b1505ca-ede7-48d9-ba95-0939fc90b84c 32 fields · synced May 29, 2026