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Nucleic Acid Extraction Reagents (Magnetic Bead)
EUDAMEDClass A (EU MDR)
Ref LTN010101
Identity
- Trade Name
- Nucleic Acid Extraction Reagents (Magnetic Bead) EUDAMED
- Device Name
- Nucleic Acid Extraction Reagents (Magnetic Bead) EUDAMED
- Model / Reference
- LTN010101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972129852348 EUDAMED
- Basic UDI-DI
- 697212985NAERN8 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Nucleic Acid Extraction Reagents (Magnetic Bead) by Hunan Lituo Biotechnology 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 | 697212985NAERN8 | Class A | Active |
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Manufacturer
- Manufacturer
- Hunan Lituo Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000029972
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 71065e3d-ad76-4f28-a671-346af48c6823 61 fields · synced Jun 18, 2026