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Infusion Pump
EUDAMEDClass IIb (EU MDR)
Ref 999.01000-19Model HK-100Ref 999.01002-29Model HK-100IIRef 999.01001-16Model HK-100IRef 908 VModel InnoFusion IF-50, 908 V, 907 VRef 907 VRef IF-50
Identity
- Trade Name
- Infusion Pump EUDAMED
- Device Name
- Infusion Pump EUDAMED
- Model / Reference
- HK-100 EUDAMED999.01000-19 EUDAMEDHK-100II EUDAMED999.01002-29 EUDAMEDHK-100I EUDAMED999.01001-16 EUDAMEDInnoFusion IF-50, 908 V, 907 V EUDAMED908 V EUDAMED907 V EUDAMEDIF-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06920506540005K4 EUDAMEDD-06920506540081KL EUDAMEDD-06920506540043KC EUDAMED06920506542849 EUDAMED06920506542832 EUDAMED06920506542290 EUDAMED06920506542825 EUDAMED06920506542856 EUDAMED
- Basic UDI-DI
- B-06920506540005K4 EUDAMEDB-06920506540081KL EUDAMEDB-06920506540043KC EUDAMED692050654228-4231BY EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDGermany EUDAMEDItaly EUDAMEDIreland 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
Infusion Pump by Shenzhen Hawk Medical Instrument Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06920506540005K4 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06920506540005K4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Hawk Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000013071
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (8)
- EUDAMED 4aa0f84d-147d-4483-a12d-a5754e65fb90 61 fields · synced Jul 30, 2026
- EUDAMED e98edbb6-b19d-4d1f-8b80-cf530556c590 61 fields · synced May 17, 2026
- EUDAMED 6e088bdc-647c-484e-b201-6b0ed92acdb6 61 fields · synced May 17, 2026
- EUDAMED 971e88f5-0f5e-475e-a080-ece10b7fc511 61 fields · synced Jul 8, 2026
- EUDAMED 766681ab-4867-4e27-9374-a1135bc5b393 61 fields · synced Jul 11, 2026
- EUDAMED abaacfc9-be0e-455d-89e9-1f7a9966c264 61 fields · synced Jul 18, 2026
- EUDAMED b9865144-2e60-4079-9d89-fac18670e4dc 61 fields · synced Jul 19, 2026
- EUDAMED 5e296e1f-ef8b-4d11-a780-2a8e86e7c22f 61 fields · synced Jul 30, 2026