Identity
- Device Name
- Quality Assurance Sources EUDAMED
- Model / Reference
- A1952 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810117211363 EUDAMED
- Basic UDI-DI
- 081011721QAK5 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
Quality Assurance 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 | 081011721QAK5 | 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 a4681427-b525-4e86-b483-f7e32f972cd7 61 fields · synced Jun 14, 2026