Identity
- Trade Name
- Upper Port Film Graticule for MLC EUDAMEDVarian Collimator Accessories Upper port film graticule for MLC FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- Collimators Accessories EUDAMED
- Model / Reference
- 890030 EUDAMED89003005 FDA UDI89003004 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858086006528 EUDAMEDFDA UDI00858086006757 FDA UDI
- Basic UDI-DI
- 089947500200138PZ EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMEDZ11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Linear accelerator system 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Upper Port Film Graticule for MLC 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 | 089947500200138PZ | 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 (4)
- EUDAMED af293d7e-a77d-42a3-9658-335db1983da5 61 fields · synced Jul 31, 2026
- FDA UDI c60f6604-d8f9-4cf8-b3a3-2b0514851f8d 33 fields · synced May 22, 2026
- FDA UDI 8c00763e-e47c-40f4-afdf-e5e1fe1f04a1 33 fields · synced May 30, 2026
- EUDAMED 9064ec8a-da80-4b81-8fca-075864ca5b48 61 fields · synced Jul 31, 2026