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Nucleic Acid Extraction Reagent
EUDAMEDClass A (EU MDR)
Ref 200801Model MEB-16C, MEB-96C, MEB-100F, MEB-16D, MEB-96DRef 200401Model Pathogen DNA (Spin-Column)Ref 201001Model MEG-16C, MEG-96C, MEG-100FRef 2001FCModel MNP-16C, MNP-96C, MNP-100F, MNP-96E Ref 200901Model MES-16C, MES-96C, MES-100FRef 200601Model MCP-16C, MCP-96C, MCP-100F, MCP-96ERef 201101Model QIARef 2002WBModel Human Whole Blood DNA (Spin-Column)
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 EUDAMEDPathogen DNA (Spin-Column) EUDAMED200401 EUDAMEDMEG-16C, MEG-96C, MEG-100F EUDAMED201001 EUDAMEDMNP-16C, MNP-96C, MNP-100F, MNP-96E EUDAMED2001FC EUDAMEDMES-16C, MES-96C, MES-100F EUDAMED200901 EUDAMEDMCP-16C, MCP-96C, MCP-100F, MCP-96E EUDAMED200601 EUDAMEDQIA EUDAMED201101 EUDAMEDHuman Whole Blood DNA (Spin-Column) EUDAMED2002WB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931302294 EUDAMED06955931304793 EUDAMED06955931304809 EUDAMED06955931304410 EUDAMED06955931304427 EUDAMED06955931302515 EUDAMED06955931302270 EUDAMED06955931302317 EUDAMED06955931302492 EUDAMED06955931302287 EUDAMED06955931302263 EUDAMED06955931304397 EUDAMED06955931304779 EUDAMED06955931304724 EUDAMED06955931302355 EUDAMED06955931302485 EUDAMED06955931304380 EUDAMED
- Basic UDI-DI
- 695593130020080001HY EUDAMED695593130020040001GL EUDAMED695593130020100001FM EUDAMED695593130020010603GM EUDAMED695593130020090001JB EUDAMED695593130020060001HA EUDAMED695593130020110001FY EUDAMED695593130020022302GV EUDAMED
- Direct Marketing DI
- 06955931304793 EUDAMED06955931304809 EUDAMED06955931304410 EUDAMED06955931304427 EUDAMED06955931304397 EUDAMED06955931304779 EUDAMED06955931304724 EUDAMED06955931304380 EUDAMED
- EMDN Code
- W0105900103 SUPPLEMENTAL NA REAGENTS EUDAMEDW0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS 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 (17)
- EUDAMED e1e80493-46d2-4312-b104-809c3a775cec 61 fields · synced Aug 3, 2026
- EUDAMED fe345f4d-ead1-40e8-ba7f-eda4acb29507 61 fields · synced May 16, 2026
- EUDAMED e1079dc5-c8be-4a3f-817b-6f37885db4be 61 fields · synced May 16, 2026
- EUDAMED 011cadce-f61a-412e-b8e3-2f2486aec5c2 61 fields · synced May 16, 2026
- EUDAMED f15a6ee6-10ca-4cca-a128-9b70f19caee0 61 fields · synced May 16, 2026
- EUDAMED e057c1e5-0ca5-4718-951f-a23ee45c5b5a 61 fields · synced May 16, 2026
- EUDAMED dfe8c176-8c68-46f6-baa8-4437f6934639 61 fields · synced May 17, 2026
- EUDAMED 541149d9-26e4-48db-8a13-18e700753ab7 61 fields · synced May 17, 2026
- EUDAMED 6a0a2612-ee7a-4d51-9ddd-1193f3822a47 61 fields · synced May 17, 2026
- EUDAMED c98be1f2-1eb2-4cdf-9063-aece26d623a0 61 fields · synced May 17, 2026
- EUDAMED ba26f3dc-ef74-4c30-8195-503aa22b2695 61 fields · synced May 18, 2026
- EUDAMED b4861192-3654-412e-a1b5-246add4d5f75 61 fields · synced May 19, 2026
- EUDAMED a0183f55-879c-44af-af08-94858f1822db 61 fields · synced May 19, 2026
- EUDAMED 7eaec354-3fdc-4087-844d-8d61b4ea2cba 61 fields · synced May 19, 2026
- EUDAMED ee21bfd7-008c-4de8-ba99-2115746546e3 61 fields · synced May 19, 2026
- EUDAMED a3bbf56e-a8f6-4342-a180-3e54860736a5 61 fields · synced May 19, 2026
- EUDAMED 75c762aa-7db6-46c5-af56-6f4365286c38 61 fields · synced May 19, 2026