Identity
- Trade Name
- RPM Gating Marker Block (2 Dot) EUDAMEDVarian RPM Gating Marker Block (2 Dot) FDA UDI
- Generic Name
- Real-time position management respiratory gating system, optical FDA UDI
- Device Name
- Marker Blocks EUDAMED
- Model / Reference
- 110708102 EUDAMED1107081-02 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858086006610 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200109PS EUDAMED
- 510(k) Number
- K102024 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Real-time position management respiratory gating system, optical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
RPM Gating Marker Block (2 Dot) by Varian Medical Systems, Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500200109PS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 9ae0c7d0-8e82-4aaf-a985-9a4e1eb71717 61 fields · synced Jun 18, 2026
- FDA UDI 0baf309b-dd1c-48a2-ab90-710463475434 33 fields · synced May 30, 2026