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HER2 amplification digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref "Model: HE01-Q24, Specification: 24 Tests Model: HE01-Y24, Specification: 24 Tests"Model HE01-Q24, HE01-Y24,Ref 12633-2Model HE01-Y24Ref 12633-1Model HE01-Q24
Identity
- Trade Name
- HER2 amplification digital PCR detection kit EUDAMED
- Device Name
- HER2 amplification digital PCR detection kit EUDAMED
- Model / Reference
- HE01-Q24, HE01-Y24, EUDAMED"Model: HE01-Q24, Specification: 24 Tests Model: HE01-Y24, Specification: 24 Tests" EUDAMEDHE01-Y24 EUDAMED12633-2 EUDAMEDHE01-Q24 EUDAMED12633-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626216 EUDAMED06974689627152 EUDAMED
- Basic UDI-DI
- B-06974689626216 EUDAMEDB-06974689627152 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMEDW01060213 HER-2/NEU (BREAST CANCER) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland 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
HER2 amplification digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974689626216 | Class IVD General | 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 (5)
- EUDAMED c34ac64b-003e-416e-a47d-dd8186de14a9 61 fields · synced Jul 8, 2026
- EUDAMED c34ac64b-003e-416e-a47d-dd8186de14a9-1 61 fields · synced Jun 10, 2026
- EUDAMED c34ac64b-003e-416e-a47d-dd8186de14a9-2 61 fields · synced Jun 10, 2026
- EUDAMED 80fa5222-2a9d-4e6e-8901-7a0413829845 61 fields · synced Jun 18, 2026
- EUDAMED 40c41448-d83c-4d69-9b7b-c5586a18026e 61 fields · synced Jun 19, 2026