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Digital PCR Universal Kit
EUDAMEDClass A (EU MDR)
Ref 10132Model 30mL/90mL/450mL
Identity
- Trade Name
- Digital PCR Universal Kit EUDAMED
- Device Name
- Digital PCR Universal Kit EUDAMED
- Model / Reference
- 30mL/90mL/450mL EUDAMED10132 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689625226 EUDAMED
- Basic UDI-DI
- 697468962522SA EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Digital PCR Universal Kit 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 | 697468962522SA | 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 (1)
- EUDAMED 9179c1ea-7235-400a-b16c-3e44a75a21fb 61 fields · synced Jun 19, 2026