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Eckert & Ziegler Isotope Products, Inc.
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref A1103
Identity
- Trade Name
- Eckert & Ziegler Isotope Products, Inc. FDA UDI
- Generic Name
- Radionuclide source, quality assurance FDA UDI
- Device Name
- Medical Check Standard Sources EUDAMEDType R3 Medical Check Standards Source FDA UDI
- Model / Reference
- A1103 EUDAMEDFDA UDI
- Description
- Type R3 Medical Check Standards Source FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810117210854 EUDAMEDFDA UDI
- Basic UDI-DI
- 081011721MCJV EUDAMED
- FDA Product Code
- IXD FDA UDI
- EMDN Code
- Z11029099 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - 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
- Germany 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radionuclide source, quality assurance
Eckert & Ziegler Isotope Products, Inc. by Eckert & Ziegler Isotope Products — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Radionuclide source, quality assurance.
- RadQual — RADQUAL, LLC · Class I
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- RadQual — RADQUAL, LLC · Class I
- RadQual — RADQUAL, LLC · Class I
- RadQual — RADQUAL, LLC · Class I
- RadQual — RADQUAL, LLC · Class I
- RadQual — RADQUAL, LLC · Class I
- RadQual — RADQUAL, LLC · 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
- Eckert & Ziegler Isotope Products
Sources (2)
- FDA UDI 5d5bf90d-abad-4542-906a-7823630d7832 33 fields · synced Jun 19, 2026
- EUDAMED 02b81678-23da-40b0-b4e3-1d270be89d04 61 fields · synced Jun 19, 2026