Identity
- Trade Name
- Nucleic Acid Extraction Reagent EUDAMED
- Device Name
- Nucleic Acid Extraction Reagent EUDAMED
- Model / Reference
- DRNAB EUDAMED8934011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973471967322 EUDAMED
- Basic UDI-DI
- 697347196893NAEAX EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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 Reagent by Shenzhen Dakewe Bio-Engineering 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 | 697347196893NAEAX | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000002174
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 0cc66cb3-8b2f-44a2-84a0-2978d48b8b87 61 fields · synced Jul 18, 2026