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Dose Calibrator Vial Sources
EUDAMEDFDA UDIClass I (EU MDR)
Ref A1910-8Ref A1910-9
Identity
- Trade Name
- Eckert & Ziegler Isotope Products, Inc. FDA UDI
- Generic Name
- Radionuclide source, quality assurance FDA UDI
- Device Name
- Dose Calibrator Vial Sources EUDAMEDDose Calibrator Vial 20mL FDA UDIDose Calibrator Vial 10mL FDA UDI
- Model / Reference
- A1910-8 EUDAMEDFDA UDIA1910-9 EUDAMEDFDA UDI
- Description
- Dose Calibrator Vial 20mL FDA UDIDose Calibrator Vial 10mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810117211097 EUDAMEDFDA UDI00810117211103 EUDAMEDFDA UDI
- Basic UDI-DI
- 081011721RVLJ 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 EUDAMEDFrance 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
Dose Calibrator Vial Sources by Eckert & Ziegler Isotope Products — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081011721RVLJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Eckert & Ziegler Isotope Products
- EUDAMED SRN
- US-MF-000020074
- Authorised Representative
- Eckert & Ziegler Nuclitec GmbH DE-AR-000016532
Sources (4)
- EUDAMED 0cdae6e7-3e1a-4830-a88c-00c8c720357d 61 fields · synced Oct 6, 2026
- FDA UDI f12f6f25-b29d-44f9-98f8-775318fd5a62 33 fields · synced May 29, 2026
- FDA UDI 6f4de622-f9df-4d8f-b4ac-e2a6f48b2369 33 fields · synced May 30, 2026
- EUDAMED 67034699-58b7-4a4d-b487-7baac250c2b4 61 fields · synced Jul 15, 2026