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Sapphire-infusionspomp
EUDAMEDClass IIb (EU MDR)
Ref 15031-000-0011Model Infusion Pump
Identity
- Trade Name
- Sapphire-infusionspomp EUDAMED
- Device Name
- Sapphire Infusion Pump EUDAMED
- Model / Reference
- Infusion Pump EUDAMED15031-000-0011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290109155418 EUDAMED
- Basic UDI-DI
- 7290109150001WP EUDAMED
- Direct Marketing DI
- 07290109155418 EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Sapphire-infusionspomp by Eitan Medical Ltd — 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 | 7290109150001WP | Class IIb | Active |
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Manufacturer
- Manufacturer
- Eitan Medical Ltd
- EUDAMED SRN
- IL-MF-000011869
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED d2b04ef8-dfd0-4490-b76a-f5d54adc23bb 61 fields · synced Jul 15, 2026