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Епидурална инфузионна помпа Sapphire
EUDAMEDClass IIb (EU MDR)
Ref 15032-000-1063Model Infusion Pump
Identity
- Trade Name
- Епидурална инфузионна помпа Sapphire EUDAMED
- Device Name
- Sapphire Infusion Pump EUDAMED
- Model / Reference
- Infusion Pump EUDAMED15032-000-1063 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290109155500 EUDAMED
- Basic UDI-DI
- 7290109150001WP EUDAMED
- Direct Marketing DI
- 07290109155500 EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria 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
Епидурална инфузионна помпа Sapphire 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 cb279f05-fa64-41c4-b444-f49767f0b6c5 61 fields · synced Jul 22, 2026