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Nucleic Acid Extraction Reagent
EUDAMEDClass A (EU MDR)
Ref LZD002-32YModel V2-D/R-64JRef LZD001-32YIIModel V1-D/R-64JⅠRef LZD001-32YⅠRef LZD001-64YIIRef LZD002-64JRef LZD001-32JⅠ
Identity
- Device Name
- Nucleic Acid Extraction Reagent EUDAMED
- Model / Reference
- V2-D/R-64J EUDAMEDLZD002-32Y EUDAMEDV1-D/R-64JⅠ EUDAMEDLZD001-32YII EUDAMEDLZD001-32YⅠ EUDAMEDLZD001-64YII EUDAMEDLZD002-64J EUDAMEDLZD001-32JⅠ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440266 EUDAMED06975102440198 EUDAMED06975102440150 EUDAMED06975102440204 EUDAMED06975102440280 EUDAMED06975102440228 EUDAMED
- Basic UDI-DI
- 697510244LZD002FR EUDAMED697510244LZD001FP EUDAMED
- Direct Marketing DI
- 06975102440266 EUDAMED06975102440198 EUDAMED06975102440150 EUDAMED06975102440204 EUDAMED06975102440280 EUDAMED06975102440228 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Category: Nucleic acid extraction/isolation kit IVD
Nucleic Acid Extraction Reagent by Jiangsu Qitian Gene biotechnology Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 697510244LZD002FR | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Qitian Gene biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000050877
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (6)
- EUDAMED 9141e603-1551-41f2-8635-4836c8afa747 61 fields · synced Aug 3, 2026
- EUDAMED 3df370cf-d58b-4bbe-96e0-3982435a6b01 61 fields · synced May 17, 2026
- EUDAMED 57cda7a0-6f85-4d72-8e62-5660eaf00d93 61 fields · synced May 17, 2026
- EUDAMED 3f656847-b3bf-4eb7-86df-cbc3817c5afd 61 fields · synced May 17, 2026
- EUDAMED af70b8fb-9961-4d21-8bdc-128813241523 61 fields · synced May 17, 2026
- EUDAMED e366681d-486f-478a-a8ac-eec6ded6fbee 61 fields · synced May 18, 2026