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Nucleic acid release agent（DNA）
EUDAMEDFDA UDIClass A (EU MDR)
Ref 52521Ref 11128Model easyDNA -B1、easyDNA -T1
Identity
- Trade Name
- Nucleic acid release agent（DNA） EUDAMEDNucleic acid release agent (DNA ) EUDAMEDTARGETINGONE FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- N/A EUDAMEDNucleic acid release agent (DNA ) EUDAMEDModel: FFPE DNA-P1, Specification: 64 tests/box FDA UDI
- Model / Reference
- 52521 EUDAMEDeasyDNA -B1、easyDNA -T1 EUDAMED11128 EUDAMEDNucleic acid extraction reagent (FFPE DNA)/FFPE DNA-P1 FDA UDI
- Description
- Model: FFPE DNA-P1, Specification: 64 tests/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974689625110 EUDAMED06974689624083 EUDAMEDFDA UDI
- Basic UDI-DI
- 697468962511S5 EUDAMED
- FDA Product Code
- PEG FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Belgium EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Nucleic acid release agent（DNA） 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 | 697468962511S5 | 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 (3)
- EUDAMED a90db62b-759f-41e9-a702-75a807807d59 61 fields · synced Jul 11, 2026
- FDA UDI 15925f46-5400-4098-b104-cee58029b806 33 fields · synced May 30, 2026
- EUDAMED b3737ef0-c2ff-4297-b5a9-9bfd49d2b004 61 fields · synced Jul 11, 2026