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Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit
EUDAMEDClass A (EU MDR)
Ref HWTS-3008-1Ref HWTS-3008-3Ref HWTS-3008-4
Identity
- Trade Name
- Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit EUDAMED
- Device Name
- Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit EUDAMED
- Model / Reference
- HWTS-3008-1 EUDAMEDHWTS-3008-3 EUDAMEDHWTS-3008-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974849366228 EUDAMED06974849366686 EUDAMED06974849366693 EUDAMED
- Basic UDI-DI
- 697484936W05019099Y8 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER 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
No
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
Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697484936W05019099Y8 | 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 d58a35af-baf1-4010-9e4a-ea48c47efd1d 61 fields · synced Jul 17, 2026
- EUDAMED 784a3390-bbf7-42c0-ac6b-a7d98f66f188 61 fields · synced May 16, 2026
- EUDAMED 17008b6f-8642-4691-8b48-27e3a36c00c2 61 fields · synced May 17, 2026