Identity
- Trade Name
- RADII FDA UDI
- Generic Name
- X-ray tube housing assembly, diagnostic FDA UDI
- Model / Reference
- H2108X FDA UDI
Identifiers
- Catalog Number
- H2108X-0.6/1.2-150-V1 FDA UDI
- Primary DI / UDI-DI
- 06971564630603 FDA UDI
- FDA Product Code
- ITY FDA UDI
- GMDN Term
- X-ray tube housing assembly, diagnostic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1760 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Radii by Hangzhou Kailong Medical Instruments Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hangzhou Kailong Medical Instruments Co., Ltd.
Sources (1)
- FDA UDI 8162806c-04b5-4c61-8a03-d35ec52fc3f5 34 fields · synced May 30, 2026