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Ambulatory Infusion Pump
EUDAMEDClass IIb (EU MDR)
Ref ELFensor P6Model ELFensor P2、ELFensor P5、ELFensor P8、ELFensor P3、ELFensor P6、ELFensor P9
Identity
- Device Name
- Ambulatory Infusion Pump EUDAMED
- Model / Reference
- ELFensor P2、ELFensor P5、ELFensor P8、ELFensor P3、ELFensor P6、ELFensor P9 EUDAMEDELFensor P6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604731 EUDAMED
- Basic UDI-DI
- 69268026IP2100000000001DB EUDAMED
- Direct Marketing DI
- 06926802604731 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
Ambulatory Infusion Pump by Medcaptain Medical Technology Co., 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 | 69268026IP2100000000001DB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1e287f0f-93bd-4464-a9bf-021d4727d874 61 fields · synced Jun 19, 2026