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Nucleic Acid Purification System
EUDAMEDClass A (EU MDR)
Ref INST040024CEModel NAE24 PIus
Identity
- Device Name
- Nucleic Acid Purification System EUDAMED
- Model / Reference
- NAE24 PIus EUDAMEDINST040024CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975970650026 EUDAMED
- Basic UDI-DI
- 697597065INST04ZN EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Nucleic Acid Purification System by Singlera Genomics (jiangsu) 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 | 697597065INST04ZN | Class A | Active |
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Manufacturer
- Manufacturer
- Singlera Genomics (jiangsu) Ltd.
- EUDAMED SRN
- CN-MF-000033428
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 30b13588-50dd-460c-9ac9-944c8e86592b 61 fields · synced Jun 18, 2026