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Nucleic Acid Extraction or Purification Kit
EUDAMEDClass IVD General (EU MDR)
Ref 18-04-0024Model Type B: 64 reactions/ kitRef 18-04-0033Model Type A: 40 reactions/ kitRef 18-04-0070Model Bulk Type B: 48 reactions/ kitRef 18-04-0035Model Type A: 20 reactions/ kitRef 18-04-0069Model Bulk Type A: 48 reactions/ kitRef 18-04-0039Model Type B: 20 reactions/ kitRef 18-04-0038Model Type B: 36 reactions/ kitRef 18-04-0032Model Type A: 48 reactions/ kitRef 18-04-0025Model Type B: 32 reactions/ kitRef 18-04-0034Model Type A: 36 reactions/ kit
Identity
- Trade Name
- Nucleic Acid Extraction or Purification Kit EUDAMED
- Device Name
- Nucleic Acid Extraction or Purification Kit EUDAMED
- Model / Reference
- Type B: 64 reactions/ kit EUDAMED18-04-0024 EUDAMEDType A: 40 reactions/ kit EUDAMED18-04-0033 EUDAMEDBulk Type B: 48 reactions/ kit EUDAMED18-04-0070 EUDAMEDType A: 20 reactions/ kit EUDAMED18-04-0035 EUDAMEDBulk Type A: 48 reactions/ kit EUDAMED18-04-0069 EUDAMEDType B: 20 reactions/ kit EUDAMED18-04-0039 EUDAMEDType B: 36 reactions/ kit EUDAMED18-04-0038 EUDAMEDType A: 48 reactions/ kit EUDAMED18-04-0032 EUDAMEDType B: 32 reactions/ kit EUDAMED18-04-0025 EUDAMEDType A: 36 reactions/ kit EUDAMED18-04-0034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674891995 EUDAMED06974674891902 EUDAMED06974674895009 EUDAMED06974674891872 EUDAMED06974674891865 EUDAMED06974674891940 EUDAMED06974674891964 EUDAMED06974674891919 EUDAMED06974674891957 EUDAMED06974674891896 EUDAMED
- Basic UDI-DI
- B-06974674891995 EUDAMEDB-06974674891902 EUDAMEDB-06974674895009 EUDAMEDB-06974674891872 EUDAMEDB-06974674891865 EUDAMEDB-06974674891940 EUDAMEDB-06974674891964 EUDAMEDB-06974674891919 EUDAMEDB-06974674891957 EUDAMEDB-06974674891896 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Category: Nucleic acid extraction/isolation kit IVD
Nucleic Acid Extraction or Purification Kit by Shenzhen Zijian Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974674891995 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (10)
- EUDAMED 02061fa3-77bd-4347-be1f-66dd89251dde 61 fields · synced Aug 3, 2026
- EUDAMED 45294bc7-53e9-4378-90f4-07889f0f5a0b 61 fields · synced May 16, 2026
- EUDAMED 76b2b114-fb28-437d-a8e6-2720c8a147fe 61 fields · synced May 16, 2026
- EUDAMED 0db215ea-23b5-4cf1-84d6-0cbc37fc55dc 61 fields · synced May 17, 2026
- EUDAMED 750c4049-3484-431b-a341-fde7dc27e8b9 61 fields · synced May 17, 2026
- EUDAMED 94132720-da88-4f6b-860d-b61af7e074a3 61 fields · synced May 18, 2026
- EUDAMED 75cc75ee-5011-4220-8c90-8e67f9f5296d 61 fields · synced May 18, 2026
- EUDAMED 704b6468-59f8-4217-b5de-c7676d71f4ac 61 fields · synced May 18, 2026
- EUDAMED d9ed126c-57d8-43ca-bdcd-09bc8fa5bb59 61 fields · synced May 18, 2026
- EUDAMED a27a8d15-eec7-4904-a5d3-d84754dbcb40 61 fields · synced May 19, 2026