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Spinal muscular atrophy (SMA) digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref "Model: SM01-Q32; Specification: 32 Tests Model: SM01-Y32; Specification: 32 Tests"Model SM01-Q32; , SM01-Y32;Ref 13203-1Model SM01-Q32
Identity
- Trade Name
- Spinal muscular atrophy (SMA) digital PCR detection kit EUDAMED
- Device Name
- Spinal muscular atrophy (SMA) digital PCR detection kit EUDAMED
- Model / Reference
- SM01-Q32; , SM01-Y32; EUDAMED"Model: SM01-Q32; Specification: 32 Tests Model: SM01-Y32; Specification: 32 Tests" EUDAMEDSM01-Q32 EUDAMED13203-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626100 EUDAMED
- Basic UDI-DI
- B-06974689626100 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMEDW0106010199 MONOGENETIC DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Spinal muscular atrophy (SMA) 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-06974689626100 | 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 (4)
- EUDAMED 18533ef0-c8da-494b-b762-c9c48a657045 61 fields · synced Jun 19, 2026
- EUDAMED 18533ef0-c8da-494b-b762-c9c48a657045-1 61 fields · synced Jun 10, 2026
- EUDAMED 18533ef0-c8da-494b-b762-c9c48a657045-2 61 fields · synced Jun 10, 2026
- EUDAMED 8fac6c4f-0e5a-4b02-9ec3-b802b574abea 61 fields · synced Jun 19, 2026