Identity
- Trade Name
- RadQual FDA UDI
- Generic Name
- Radiographic image marker, manual FDA UDI
- Device Name
- Marker Sources EUDAMED1" Dia. Al Spot Source Ge-68 FDA UDI
- Model / Reference
- BM03-68A-<25 EUDAMEDBM03-68A FDA UDI
- Description
- 1" Dia. Al Spot Source Ge-68 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850020470143 EUDAMEDFDA UDI
- Basic UDI-DI
- 0085002047MARKERNJ EUDAMED
- FDA Product Code
- IXD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Radiographic image marker, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1400 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: Radiographic image marker, manual
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 45bd95ec-bb8b-4925-b0f2-562ffb791a97 33 fields · synced Jun 19, 2026
- EUDAMED 13fe07d7-8c04-46a3-ae05-5a36a378d4cb 61 fields · synced Jun 19, 2026