Identity
- Trade Name
- 40um Tandem 2mL - INTL EUDAMED
- Device Name
- TANDEM EUDAMED
- Model / Reference
- 10420-TS0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810563021363 EUDAMED
- Basic UDI-DI
- 089947500200141PN EUDAMED
- EMDN Code
- C010402020303 EMBOLISATION PARTICLES AND MICROSPHERES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
40um Tandem 2mL - INTL by Varian Medical Systems, Inc — Class III — 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 | 089947500200141PN | Class III | 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 edb43f5d-0ece-4627-ba0d-eada672770ed 61 fields · synced Jun 18, 2026