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Saliva Collection Kit
EUDAMEDClass A (EU MDR)
Ref CY-98000D-2Model CY-98000A, CY-98000B, CY-98000C-1, CY-98000C-2, CY-98000C, CY-98000D-1, CY-98000D-2, CY-98000-P2
Identity
- Trade Name
- Saliva Collection Kit EUDAMED
- Device Name
- Saliva Collection Kit EUDAMED
- Model / Reference
- CY-98000A, CY-98000B, CY-98000C-1, CY-98000C-2, CY-98000C, CY-98000D-1, CY-98000D-2, CY-98000-P2 EUDAMEDCY-98000D-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974488991980 EUDAMED
- Basic UDI-DI
- 697448899CY-98/0/4/2/8V38 EUDAMED
- EMDN Code
- W0104010203 TRANSPORT MEDIA EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Saliva Collection Kit by Huachenyang (Shenzhen) Technology 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 | 697448899CY-98/0/4/2/8V38 | Class A | Active |
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Manufacturer
- Manufacturer
- Huachenyang (Shenzhen) Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020236
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED c29f64d4-235f-4b45-82e0-656a867e4584 61 fields · synced Oct 5, 2026