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Nucleic Acid Extraction and Purification Kit (Column)
EUDAMEDClass A (EU MDR)
Ref 50 tests/ kitModel 50 tests/ kit, 1 100 tests/ kitRef 100 tests/ kit
Identity
- Device Name
- Nucleic Acid Extraction and Purification Kit (Column) EUDAMED
- Model / Reference
- 50 tests/ kit, 1 100 tests/ kit EUDAMED50 tests/ kit EUDAMED100 tests/ kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491760006 EUDAMED06975491760013 EUDAMED
- Basic UDI-DI
- 697549176NAEAPK01DZ EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Category: Nucleic acid extraction/isolation kit IVD
Nucleic Acid Extraction and Purification Kit (Column) by Shenzhen Sciarray Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 697549176NAEAPK01DZ | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Sciarray Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000038307
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 1f07f034-3522-49e5-8cbf-5fe4c9702b7d 61 fields · synced Jul 12, 2026
- EUDAMED 560f6235-896e-45dc-a812-d4e1e65c7438 61 fields · synced May 18, 2026