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Guided Aarhus Applicator Set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref GM11013900
Identity
- Trade Name
- Guided Aarhus Applicator Set EUDAMED
- Device Name
- Guided Aarhus Appicator Set EUDAMED
- Model / Reference
- GM11013900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816389028937 EUDAMED
- Basic UDI-DI
- 089947500201041PQ EUDAMED
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Guided Aarhus Applicator Set by Varian Medical Systems, Inc — 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 | K252884 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201041PQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED 95292902-af3f-4699-8ead-cf2855b8b312 61 fields · synced Jul 22, 2026
- FDA 510(k) K252884 1 fields · synced May 18, 2026