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Syringe Pump
EUDAMEDClass IIb (EU MDR)
Ref 999.04003-18Model HK-400III Ref 999.04001-12Model HK-400I Ref 999.04002-01Model HK-400II Ref 999.000s1-16Model hawk-s1
Identity
- Device Name
- Syringe Pump EUDAMED
- Model / Reference
- HK-400III EUDAMED999.04003-18 EUDAMEDHK-400I EUDAMED999.04001-12 EUDAMEDHK-400II EUDAMED999.04002-01 EUDAMEDhawk-s1 EUDAMED999.000s1-16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06920506540487LL EUDAMEDD-06920506540425KW EUDAMEDD-06920506540449LC EUDAMEDD-06920506540562L9 EUDAMED
- Basic UDI-DI
- B-06920506540487LL EUDAMEDB-06920506540425KW EUDAMEDB-06920506540449LC EUDAMEDB-06920506540562L9 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-06920506540487LL | 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 (4)
- EUDAMED ec4ab626-1b41-4ae3-9c7f-42d7c5cc106c 61 fields · synced Jul 28, 2026
- EUDAMED b050add4-9913-4f94-a263-0b56bd18d045 61 fields · synced May 18, 2026
- EUDAMED a2b8b593-f0cc-47ad-9a61-ed884d2720e2 61 fields · synced May 19, 2026
- EUDAMED 4909e757-9fa8-4eac-8aca-8b32c2b221ab 61 fields · synced May 19, 2026