Identity
- Trade Name
- Water Reservoir FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Waterreservoir - bidirectional pump, 230V FDA UDI
- Model / Reference
- HA05-000 FDA UDI
- Description
- Waterreservoir - bidirectional pump, 230V FDA UDI
Identifiers
- Catalog Number
- HA05-000 FDA UDI
- Primary DI / UDI-DI
- EIBAHA050000 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Accelerator system quality assurance device
A comprehensive medical device designed for quality assurance in linear and non-linear medical accelerator systems used for radiation therapy applications.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- IBA Dosimetry GmbH
Sources (1)
- FDA UDI b7bce014-922c-4355-9348-1213c6fb569b 35 fields · synced Jul 25, 2026