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Saliva Collection Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref CY-98000AModel 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 EUDAMEDiClean FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection kit IVD, home-use FDA UDI
- 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-98000A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974488991935 EUDAMED16974488990386 FDA UDI
- Basic UDI-DI
- 697448899CY-98/0/4/2/8V38 EUDAMED
- EMDN Code
- W0104010203 TRANSPORT MEDIA EUDAMED
- GMDN Term
- Oral/upper respiratory tract specimen collection kit IVD, home-use FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Saliva Collection Kit by Huachenyang (Shenzhen) Technology Co., Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697448899CY-98/0/4/2/8V38 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (2)
- EUDAMED 8fac4c70-cc74-4d12-82bf-4b5f5153aaac 61 fields · synced Jun 18, 2026
- FDA UDI 3555d298-9bd1-47a4-bcc4-018709db528b 32 fields · synced May 30, 2026