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Macro & Micro-Test Sample Release Reagent
EUDAMEDClass A (EU MDR)
Ref HWTS-3005-8BModel Type Ⅰ: 50 tests/ kit
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-3005-8B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366891 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.
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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 (1)
- EUDAMED a0c8b07f-4a81-47aa-93d9-f2135d35df4c 61 fields · synced Jun 9, 2026