← Back to catalogue
Nucleic Acid Extraction Kit
EUDAMEDClass A (EU MDR)
Ref KH-G-M-565-48-CERef KH-G-M-572-32-CE
Identity
- Trade Name
- Nucleic Acid Extraction Kit EUDAMEDNucleic Acid Extraction Kit 32 EUDAMED
- Device Name
- Nucleic Acid Extraction Kit EUDAMEDNucleic Acid Extraction Kit 96 EUDAMED
- Model / Reference
- KH-G-M-565-48-CE EUDAMEDKH-G-M-572-32-CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971850060848 EUDAMED06971850060862 EUDAMED
- Basic UDI-DI
- 697185006MDX0001M2 EUDAMED697185006MDX0002M4 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
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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 Kit by Shanghai Kehua Bio-engineering 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 | 697185006MDX0001M2 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Kehua Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026756
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED e13012e3-458d-4e4c-bc21-f30509ddfd4c 61 fields · synced Jul 14, 2026
- EUDAMED 69805502-302d-4435-8a9a-b8dd57f95f7c 61 fields · synced May 19, 2026