← Back to catalogue
Macro & Micro-Test Bacterial DNA/RNA Kit
EUDAMEDClass A (EU MDR)
Ref HWTS-3011-32Model Type Ⅰ: 50 tests/ kit Ref HWTS-3011-96Ref HWTS-3011-48
Identity
- Trade Name
- Macro & Micro-Test Bacterial DNA/RNA Kit EUDAMED
- Device Name
- Macro & Micro-Test Viral DNA/RNA Kit EUDAMED
- Model / Reference
- Type Ⅰ: 50 tests/ kit EUDAMEDHWTS-3011-32 EUDAMEDHWTS-3011-96 EUDAMEDHWTS-3011-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366839 EUDAMED06974849366853 EUDAMED06974849366846 EUDAMED
- Basic UDI-DI
- 697484936W0105900101HP 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
Macro & Micro-Test Bacterial DNA/RNA Kit by Jiangsu Macro & Micro-Test Med-Tech 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 | 697484936W0105900101HP | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000012807
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED d3ca83f8-f347-409b-8e57-481f8c39b05b 61 fields · synced Aug 4, 2026
- EUDAMED 2a6269b5-a9a9-4fb8-b3f4-f92336c52c10 61 fields · synced May 19, 2026
- EUDAMED e9487bfb-8650-4a1a-a12b-f77df2ec7fa3 61 fields · synced May 19, 2026