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Aarhus Applicator Set
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GM11013800
Identity
- Trade Name
- Aarhus Applicator Set EUDAMEDFDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Aarhus Applicator Set EUDAMEDContains: GM11013810-00816389028036, GM11013820-00816389028043 FDA UDI
- Model / Reference
- GM11013800 EUDAMEDFDA UDI
- Description
- Contains: GM11013810-00816389028036, GM11013820-00816389028043 FDA UDI
Identifiers
- Catalog Number
- GM11013800 FDA UDI
- Primary DI / UDI-DI
- 00810563023336 EUDAMED00816389028050 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201176QG EUDAMED
- 510(k) Number
- K222775 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dry Heat Sterilization FDA UDI
MR Safe FDA UDI
Aarhus Applicator Set by Varian Medical Systems, Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K222775 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201176QG | 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 (4)
- EUDAMED 6fed7fe1-4ac0-4120-b6cf-7531fee3890d 61 fields · synced Aug 2, 2026
- EUDAMED 9b3c5a9e-6dc3-4e09-95f8-8f443dbfa5d5 61 fields · synced May 19, 2026
- FDA UDI 6deed8c4-33ad-44dd-817e-410f9c6181bd 35 fields · synced May 30, 2026
- FDA 510(k) K222775 1 fields · synced May 18, 2026