← Back to catalogue
Sapphire epidural infusionspump
EUDAMEDClass IIb (EU MDR)
Ref 15032-000-0016Model Infusion Pump
Identity
- Trade Name
- Sapphire epidural infusionspump EUDAMED
- Device Name
- Sapphire Infusion Pump EUDAMED
- Model / Reference
- Infusion Pump EUDAMED15032-000-0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290109155388 EUDAMED
- Basic UDI-DI
- 7290109150001WP EUDAMED
- Direct Marketing DI
- 07290109155388 EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark 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 epidural infusionspump 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eitan Medical Ltd
- EUDAMED SRN
- IL-MF-000011869
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED c29f64c5-4c9e-4275-8cf7-c78e833179ff 61 fields · synced Jun 18, 2026