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Macro & Micro-Test Sample Release Reagent
EUDAMEDClass A (EU MDR)
Ref HWTS-3005-8CModel Type Ⅰ: 50 tests/ kit Ref HWTS-3005-8ERef HWTS-3005-8GRef HWTS-3005-8HRef HWTS-3005-8F
Identity
- Trade Name
- Macro & Micro-Test Sample Release Reagent EUDAMED
- Device Name
- Macro & Micro-Test Viral DNA/RNA Kit EUDAMED
- Model / Reference
- Type Ⅰ: 50 tests/ kit EUDAMEDHWTS-3005-8C EUDAMEDHWTS-3005-8E EUDAMEDHWTS-3005-8G EUDAMEDHWTS-3005-8H EUDAMEDHWTS-3005-8F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366907 EUDAMED06974849366921 EUDAMED06974849366945 EUDAMED06974849366952 EUDAMED06974849368970 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 Sample Release Reagent 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 |
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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 (5)
- EUDAMED d38874cf-fbd2-41f5-9808-f6899c87534f 61 fields · synced Jul 17, 2026
- EUDAMED 4350fcee-ede3-4a99-a394-ae5ecb8a5849 61 fields · synced May 17, 2026
- EUDAMED 87dc6d46-e860-40f8-b612-2c61a3b165ce 61 fields · synced May 17, 2026
- EUDAMED 6e44078e-0c71-4dfe-aa14-08fee6cc5b0d 61 fields · synced May 18, 2026
- EUDAMED b7b99595-7fa0-4d93-88ae-517fe15a1ffd 61 fields · synced Jul 17, 2026