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Nucleic acid extraction reagent
EUDAMEDClass A (EU MDR)
Ref N/AModel B1，P1Ref 11004Model B1、P1
Identity
- Trade Name
- Nucleic acid extraction reagent EUDAMED
- Device Name
- Nucleic acid extraction reagent EUDAMED
- Model / Reference
- B1，P1 EUDAMEDN/A EUDAMEDB1、P1 EUDAMED11004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689625127 EUDAMED
- Basic UDI-DI
- 697468962512S7 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Nucleic acid extraction reagent by TargetingOne Technology (Beijing) Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697468962512S7 | Class A | Active |
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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 bef97467-ba79-4a5c-85b2-a5fedaaaba48 61 fields · synced Jun 19, 2026
- EUDAMED 8d5baa8f-e14d-4c95-9392-ec429ec15bb0 61 fields · synced Jun 19, 2026