Identity
- Trade Name
- RadQual FDA UDI
- Generic Name
- Radionuclide source, quality assurance FDA UDI
- Device Name
- Calibration Sources EUDAMEDBA-133 "E" Vial FDA UDI
- Model / Reference
- BM06E-33 EUDAMEDFDA UDI
- Description
- BA-133 "E" Vial FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850020470181 EUDAMEDFDA UDI
- Basic UDI-DI
- 0085002047CALIBRATIONUH EUDAMED
- FDA Product Code
- IXD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Radionuclide source, quality assurance 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: Radionuclide source, quality assurance
RadQual by Radqual, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radionuclide source, quality assurance.
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- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
- Eckert & Ziegler Isotope Products, Inc. — Eckert & Ziegler Isotope Products · Class I
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 15b1fcf4-6bc7-48b6-9a05-f10113bc9b7c 33 fields · synced Jul 9, 2026
- EUDAMED 17749920-381e-457c-b47c-db406bdcce74 61 fields · synced Jul 9, 2026