Identity
- Trade Name
- RadQual FDA UDI
- Generic Name
- Nuclear medicine phantom, flood source FDA UDI
- Device Name
- Flood Sources EUDAMEDSquare Digirad Phantom Co 57 FDA UDI
- Model / Reference
- BM05-05 EUDAMEDBM05 FDA UDI
- Description
- Square Digirad Phantom Co 57 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850020470037 EUDAMEDFDA UDI
- Basic UDI-DI
- 0085002047FLOODKZ EUDAMED
- FDA Product Code
- IYQ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Nuclear medicine phantom, flood source FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1380 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
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: Nuclear medicine phantom, flood source
RadQual by Radqual, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Radqual, Llc
Sources (2)
- FDA UDI ca95188c-e2f5-46b3-8087-183232f44a3b 33 fields · synced Jul 29, 2026
- EUDAMED 1809f36b-8da8-4bcb-abf2-33ebcd1d56a7 61 fields · synced Jul 29, 2026