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MAASTRO Rectal Applicator Set, ø 30 mm
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref GM11014200
Identity
- Trade Name
- MAASTRO Rectal Applicator Set, ø 30 mm EUDAMED
- Device Name
- MAASTRO Rectal Applicator Set EUDAMED
- Model / Reference
- GM11014200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816389028142 EUDAMED
- Basic UDI-DI
- 089947500201005PL 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
MAASTRO Rectal Applicator Set, ø 30 mm 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 | K252717 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201005PL | 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 339350aa-4e83-45a7-9f6a-15c75ee2cdee 61 fields · synced Jul 13, 2026
- FDA 510(k) K252717 1 fields · synced Jun 4, 2026