Identity
- Device Name
- Syringe Pump EUDAMED
- Model / Reference
- HK-400 EUDAMED999.04000-22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06920506540388LH EUDAMED
- Basic UDI-DI
- B-06920506540388LH EUDAMED
- EMDN Code
- Z12030302 SYRINGE 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
Syringe 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-06920506540388LH | 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 06a484b3-ac80-4fae-8b86-92c32509eb05 61 fields · synced Jun 19, 2026