← Back to catalogue
Ambulatory Infusion Pump
EUDAMEDClass IIb (EU MDR)
Ref ELFensor P8Model ELFensor P2、ELFensor P5、ELFensor P8、ELFensor P3、ELFensor P6、ELFensor P9Ref ELFensor P2Ref ELFensor P9Ref /Model HP-60, HP-60C, HP-60 PRO, HP-60C PRO, V700Model XP-60, XP-60 PRO, XP-60C, XP-60C PRO, XP-60T, AP-60, AP-60 PRO, AP-60C, AP-60C PRO, AP-60T
Identity
- Device Name
- Ambulatory Infusion Pump EUDAMEDInfusion pump EUDAMED
- Model / Reference
- ELFensor P2、ELFensor P5、ELFensor P8、ELFensor P3、ELFensor P6、ELFensor P9 EUDAMEDELFensor P8 EUDAMEDELFensor P2 EUDAMEDELFensor P9 EUDAMEDHP-60, HP-60C, HP-60 PRO, HP-60C PRO, V700 EUDAMED/ EUDAMEDXP-60, XP-60 PRO, XP-60C, XP-60C PRO, XP-60T, AP-60, AP-60 PRO, AP-60C, AP-60C PRO, AP-60T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802604717 EUDAMED06926802604694 EUDAMED06926802604748 EUDAMED06926802605165 EUDAMED06926802607275 EUDAMED06926802616239 EUDAMED06926802608784 EUDAMED06926802608722 EUDAMED
- Basic UDI-DI
- 69268026IP2100000000001DB EUDAMED69268026HP60000001Q7 EUDAMED69268026XP60000000000017E EUDAMED
- Direct Marketing DI
- 06926802604717 EUDAMED06926802604694 EUDAMED06926802604748 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (8)
- EUDAMED eca25fd5-a543-48c2-a691-2544c83534d6 61 fields · synced Sep 17, 2026
- EUDAMED b65cc671-886d-4f57-bf83-c54991bbf74f 61 fields · synced May 18, 2026
- EUDAMED 5a24ccb4-7e35-47eb-8af0-7424d5e5e218 61 fields · synced May 18, 2026
- EUDAMED 9ef43c30-9d46-426f-8dc3-f4f9b839553d 61 fields · synced Jul 9, 2026
- EUDAMED 26b8fc7f-a584-44a8-9d25-4e29efd65fbe 61 fields · synced Jul 22, 2026
- EUDAMED 1f6dd0e1-edad-463b-93bd-fa5a573846e5 61 fields · synced Jul 24, 2026
- EUDAMED 6bc317b6-1bb1-4749-ac8e-48b2f7f867e9 61 fields · synced Aug 3, 2026
- EUDAMED cde2a7dc-5006-45b5-be52-5007d516f579 61 fields · synced Sep 17, 2026