Identity
- Device Name
- Dose Calibrator Vial Sources EUDAMED
- Model / Reference
- A1910-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810117211387 EUDAMED
- Basic UDI-DI
- 081011721RVLJ EUDAMED
- EMDN Code
- Z11029099 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Dose Calibrator Vial Sources by Eckert & Ziegler Isotope Products — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081011721RVLJ | Class I | Active |
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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 (1)
- EUDAMED 06d9f510-8e10-49e1-b5b2-7eadc372e20f 61 fields · synced Jun 19, 2026