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Fixation button kit 2 (green, yellow, black) sterile
EUDAMEDClass IIa (EU MDR)
Ref GM11010370
Identity
- Trade Name
- Fixation button kit 2 (green, yellow, black) sterile EUDAMED
- Device Name
- Fixation Buttons EUDAMED
- Model / Reference
- GM11010370 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810563022223 EUDAMED
- Basic UDI-DI
- 089947500201117PY EUDAMED
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Fixation button kit 2 (green, yellow, black) sterile by Varian Medical Systems, Inc — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 089947500201117PY | 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 (1)
- EUDAMED dbe8bbd9-1995-4584-9220-b031924ef5f1 61 fields · synced Jul 9, 2026