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X-ray marker BV, up to 250 mm applicators, uncoded
EUDAMEDClass I (EU MDR)
Ref GM11019580
Identity
- Trade Name
- X-ray marker BV, up to 250 mm applicators, uncoded EUDAMED
- Device Name
- X-ray Marker Wires EUDAMEDGM Positioning Accessories - BV EUDAMED
- Model / Reference
- GM11019580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810563022407 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 250 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 (2)
- EUDAMED 83050cb7-b0ff-4802-9e2f-3bbd42ca0709 61 fields · synced Jun 19, 2026
- EUDAMED d66395c5-4cd3-4e1e-8ae5-e781464a8955 61 fields · synced Jun 19, 2026