← Back to catalogue
Patient Administration Set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 17839Model 17830
Identity
- Device Name
- Patient Administration Set EUDAMED
- Model / Reference
- 17830 EUDAMED17839 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09340598000046 EUDAMED
- Basic UDI-DI
- 93405980PAS36 EUDAMED
- EMDN Code
- Z11029085 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Patient Administration Set by Cyclomedica Australia Pty Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200916 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 93405980PAS36 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cyclomedica Australia Pty Ltd
- EUDAMED SRN
- AU-MF-000015872
- Authorised Representative
- Cyclomedica Europe IE-AR-000003505
Sources (2)
- EUDAMED e03d8905-1a6e-4e74-b0e1-9473367d167b 61 fields · synced Jul 22, 2026
- FDA 510(k) K200916 1 fields · synced May 18, 2026