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500um Embozene 1mL Colored - INTL
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 15010-S1
Identity
- Trade Name
- 500um Embozene 1mL Colored - INTL EUDAMEDEmbozene Color Advance 500um Embozene 1mL Colored - US FDA UDI
- Generic Name
- Embolization particle, non-bioabsorbable FDA UDI
- Device Name
- Embozene®Color-Advanced Microspheres EUDAMED
- Model / Reference
- 15010-S1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810563021264 EUDAMED00810563021530 FDA UDI
- Basic UDI-DI
- 089947500200139Q3 EUDAMED
- 510(k) Number
- K180102 FDA UDI
- FDA Product Code
- KRD FDA UDINAJ FDA UDINOY FDA UDI
- EMDN Code
- C010402020303 EMBOLISATION PARTICLES AND MICROSPHERES EUDAMED
- GMDN Term
- Embolization particle, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.3300 FDA UDI876.5550 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
500um Embozene 1mL Colored - INTL 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 | 089947500200139Q3 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000007453
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED 27f93b21-73a4-4b34-ac13-479a4e0d5b84 61 fields · synced Jul 9, 2026
- FDA UDI 8e5f205c-c920-43bf-9fcb-3f400d17ef5c 33 fields · synced May 30, 2026