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Macro & Micro-Test Viral DNA/RNA Kit
EUDAMEDClass A (EU MDR)
Ref HWTS-3017-8Model Type Ⅰ: 50 tests/ kit Ref HWTS-3017-48Ref HWTS-3017-322
Identity
- Trade Name
- Macro & Micro-Test Viral DNA/RNA Kit EUDAMED
- Device Name
- Macro & Micro-Test Viral DNA/RNA Kit EUDAMED
- Model / Reference
- Type Ⅰ: 50 tests/ kit EUDAMEDHWTS-3017-8 EUDAMEDHWTS-3017-48 EUDAMEDHWTS-3017-322 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849367904 EUDAMED06974849366549 EUDAMED06974849367874 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 Viral DNA/RNA Kit by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 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 (3)
- EUDAMED 2934862b-adbe-426d-88dc-4c7c8c8b5be2 61 fields · synced Aug 4, 2026
- EUDAMED dbedcbc5-468d-4507-b8d2-74f71d4be636 61 fields · synced May 17, 2026
- EUDAMED 4014f620-a8ec-4947-8547-3178545a7f9a 61 fields · synced May 17, 2026