Identity
- Device Name
- Infusion Pump EUDAMED
- Model / Reference
- hawk-i1 EUDAMED999.000i1-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06920506540227KQ EUDAMED
- Basic UDI-DI
- B-06920506540227KQ EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06920506540227KQ | 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 (1)
- EUDAMED f30e986a-444d-4015-85b0-9e686271a0aa 61 fields · synced Jun 20, 2026