Identity
- Trade Name
- Ir-192 Source, HDR EUDAMEDBravos HDR Ir 192 Brachytherapy Sealed Source FDA UDI
- Generic Name
- Remote-afterloading brachytherapy source FDA UDI
- Device Name
- BRAVOS Afterloader System EUDAMED
- Model / Reference
- VG32203000 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- VG32203000 FDA UDI
- Primary DI / UDI-DI
- 00816389028852 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201001PC EUDAMED
- 510(k) Number
- K191580 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010301 BRACHYTHERAPY RADIATION SYSTEMS EUDAMED
- GMDN Term
- Remote-afterloading brachytherapy source FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 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
Ir-192 Source, HDR by Varian Medical Systems, Inc — Class IIb — 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 | 089947500201001PC | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED ab8ed6cd-16f6-4b52-b792-35bd87288cb2 61 fields · synced Jul 15, 2026
- FDA UDI 96af5507-baca-4f5a-8a64-4c59f470f187 34 fields · synced May 29, 2026