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X-ray marker BV, up to 1500 mm applicators, uncoded
EUDAMEDClass I (EU MDR)
Ref GM11019590
Identity
- Trade Name
- X-ray marker BV, up to 1500 mm applicators, uncoded EUDAMED
- Device Name
- X-ray Marker Wires EUDAMED
- Model / Reference
- GM11019590 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810563022339 EUDAMED
- Basic UDI-DI
- 089947500201071PZ EUDAMED
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
X-ray marker BV, up to 1500 mm applicators, uncoded by Varian Medical Systems, Inc — Class I — 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 | 089947500201071PZ | Class I | 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 fa5cd770-77ab-4184-bb56-7795fb1dcd2f 61 fields · synced Jun 17, 2026