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Nucleic acid extraction(DNA/RNA) or purification Kit
EUDAMEDClass A (EU MDR)
Ref AA12-01-96
Identity
- Trade Name
- Nucleic acid extraction(DNA/RNA) or purification Kit EUDAMED
- Device Name
- Nucleic acid extraction(DNA/RNA) or purification Kit EUDAMED
- Model / Reference
- AA12-01-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977805760016 EUDAMED
- Basic UDI-DI
- 697780576HSTAAEXTUX EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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(DNA/RNA) or purification Kit by Shenzhen Health SwifTech Co., Ltd. — 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 | 697780576HSTAAEXTUX | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Health SwifTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000044339
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 49e5c1de-6917-4fe8-93af-479d1585fddc 61 fields · synced Jun 20, 2026