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Saliva Collection Kit
EUDAMEDClass A (EU MDR)
Ref 46010001, 46011001Model SCK-Ⅰ-1
Identity
- Device Name
- Saliva Collection Kit EUDAMED
- Model / Reference
- SCK-Ⅰ-1 EUDAMED46010001, 46011001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974481833324 EUDAMED
- Basic UDI-DI
- 69744183019001Z7 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Saliva Collection Kit by Guangzhou Improve Medical Instruments Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69744183019001Z7 | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Improve Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000006536
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b01fb67d-2e3d-43db-a061-61ee986bdece 61 fields · synced Aug 4, 2026
- EUDAMED b01fb67d-2e3d-43db-a061-61ee986bdece-1 61 fields · synced Jun 11, 2026