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Nucleic Acid Extraction Reagent
EUDAMEDClass A (EU MDR)
Ref 200801Model MEB-16C, MEB-96C, MEB-100F, MEB-16D, MEB-96D
Identity
- Trade Name
- Nucleic Acid Extraction Reagent EUDAMED
- Device Name
- Nucleic Acid Extraction Reagent EUDAMED
- Model / Reference
- MEB-16C, MEB-96C, MEB-100F, MEB-16D, MEB-96D EUDAMED200801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931302300 EUDAMED
- Basic UDI-DI
- 695593130020080001HY EUDAMED
- EMDN Code
- W0105900103 SUPPLEMENTAL NA REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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 Reagent by Yaneng BIOscience (Shenzhen) 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 | 695593130020080001HY | Class A | Active |
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Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 9797c65b-9694-4b49-b81b-a016a5737269 61 fields · synced Jun 18, 2026