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Nucleic acid extraction and purification kit
EUDAMEDClass A (EU MDR)
Ref TQ-BG-008-96D-96Model 96 tests/ kitRef TQ-BG-008-96B-96
Identity
- Trade Name
- Nucleic acid extraction and purification kit EUDAMED
- Device Name
- Nucleic acid extraction and purification kit EUDAMED
- Model / Reference
- 96 tests/ kit EUDAMEDTQ-BG-008-96D-96 EUDAMEDTQ-BG-008-96B-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974677690267 EUDAMED06974677690250 EUDAMED
- Basic UDI-DI
- 6974677690267JM EUDAMED6974677690250J4 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
Yes
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 and purification kit by Shanghai BioGerm Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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
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- 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 | 6974677690267JM | Class A | Active |
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Manufacturer
- Manufacturer
- Shanghai BioGerm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018164
- Authorised Representative
- PureMDR GmbH DE-AR-000007923
Sources (2)
- EUDAMED b1ef4a17-e859-4d13-8ca2-93e7f1f4e5b2 61 fields · synced Jul 11, 2026
- EUDAMED 9b833747-2deb-431e-8c76-636df2030a33 61 fields · synced May 18, 2026