Identity
- Trade Name
- 500um Embozene 2mL Colored - INTL EUDAMED
- Device Name
- Embozene®Color-Advanced Microspheres EUDAMED
- Model / Reference
- 15020-S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810563021271 EUDAMED
- Basic UDI-DI
- 089947500200139Q3 EUDAMED
- EMDN Code
- C010402020303 EMBOLISATION PARTICLES AND MICROSPHERES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
500um Embozene 2mL Colored - INTL by Varian Medical Systems, Inc. — Class IIb — 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 | 089947500200139Q3 | Class IIb | Active |
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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 (1)
- EUDAMED bdf54357-f37c-47fe-8b2c-4918bf5f3ea8 61 fields · synced Oct 6, 2026