Identity
- Trade Name
- iClean FDA UDI
- Generic Name
- General specimen collection kit IVD, clinical FDA UDI
- Model / Reference
- CY-93050R-TS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16974488990171 FDA UDI
- FDA Product Code
- JSM FDA UDI
- GMDN Term
- General specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: General specimen collection kit IVD, clinical
iClean by Huachenyang (Shenzhen) Technology Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General specimen collection kit IVD, clinical.
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- BioTeke — Bioteke Corporation (Wuxi) Co., Ltd. · Class I
- Therapak — Therapak LLC · Class I
- DHI Specimen Collection System — DIAGNOSTIC HYBRIDS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huachenyang (Shenzhen) Technology Co., Ltd
Sources (1)
- FDA UDI 664e2c50-1352-4d80-8bda-6b28b46a4866 32 fields · synced Jun 7, 2026