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Nucleic Acid Extraction and Methylation Conversion Kit
EUDAMEDClass A (EU MDR)
Ref 96 tests/ kitModel 8 tests/ kit, 16 tests/ kit, 32 tests/ kit, 48 tests/ kit, 96 tests/ kit
Identity
- Device Name
- Nucleic Acid Extraction and Methylation Conversion Kit EUDAMED
- Model / Reference
- 8 tests/ kit, 16 tests/ kit, 32 tests/ kit, 48 tests/ kit, 96 tests/ kit EUDAMED96 tests/ kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975491760105 EUDAMED
- Basic UDI-DI
- 697549176NAEAMCK3C EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - 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
Category: Nucleic acid extraction/isolation kit IVD
Nucleic Acid Extraction and Methylation Conversion Kit by Shenzhen Sciarray Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED
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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 | 697549176NAEAMCK3C | 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 (1)
- EUDAMED c8a4e61d-df1a-4947-9811-6c5ecc5b80bd 61 fields · synced Jun 19, 2026