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Saliva Collection Kit
EUDAMEDClass A (EU MDR)
Ref Saliva Kit 001Model Saliva Kit 001;Saliva Kit 002;Saliva Kit Without VTM 001;Saliva Kit Without VTM 002;Full Saliva Kit;Saliva Kit without VTM.
Identity
- Device Name
- Saliva Collection Kit EUDAMED
- Model / Reference
- Saliva Kit 001;Saliva Kit 002;Saliva Kit Without VTM 001;Saliva Kit Without VTM 002;Full Saliva Kit;Saliva Kit without VTM. EUDAMEDSaliva Kit 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973905960608 EUDAMED
- Basic UDI-DI
- 697390596SCK01RC EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Saliva Collection Kit by Shandong Chengwu Medical Products Factory — 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 | 697390596SCK01RC | Class A | Active |
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Manufacturer
- Manufacturer
- Shandong Chengwu Medical Products Factory
- EUDAMED SRN
- CN-MF-000003370
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b3eb95c8-2620-4d7c-8ada-bdf8dd052dbd 61 fields · synced Oct 6, 2026