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Nucleic Acid Extraction and Purification Kit
EUDAMEDClass A (EU MDR)
Ref 106-0051-01Model Single serving
Identity
- Device Name
- Nucleic Acid Extraction and Purification Kit EUDAMED
- Model / Reference
- Single serving EUDAMED106-0051-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975447582065 EUDAMED
- Basic UDI-DI
- 697544758EXTXQ EUDAMED
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Nucleic Acid Extraction and Purification Kit by Igenesis(Shanghai)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 | 697544758EXTXQ | Class A | Active |
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Manufacturer
- Manufacturer
- Igenesis(Shanghai)Co., Ltd.
- EUDAMED SRN
- CN-MF-000001552
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 2bb22b82-4f87-4655-a97d-dfac7e8f8b84 61 fields · synced Jun 18, 2026