Identity
- Trade Name
- Solid Water HE EUDAMED
- Device Name
- Solid Water HE EUDAMED
- Model / Reference
- 557 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060608881475 EUDAMED
- Basic UDI-DI
- 506060888PHSWDT EUDAMED
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - 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
Solid Water HE by Sun Nuclear Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Solid Water HE Reliable, Durable Water Equivalent Phantoms
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 | 506060888PHSWDT | Class I | Active |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
- EUDAMED SRN
- US-MF-000021541
- Authorised Representative
- Sun Nuclear GmbH DE-AR-000012933
Sources (1)
- EUDAMED d622df8a-b3b6-4063-a2dc-8d771fec767c 61 fields · synced Jul 13, 2026