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Syringe Pump
EUDAMEDClass IIb (EU MDR)
Ref Sunfusion Semi-1Ref BYZ-810SRef BYZ-810DRef Sunfusion Erch-3
Identity
- Trade Name
- Syringe Pump EUDAMED
- Device Name
- Syringe Pump EUDAMED
- Model / Reference
- Sunfusion Semi-1 EUDAMEDBYZ-810S EUDAMEDBYZ-810D EUDAMEDSunfusion Erch-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949908045 EUDAMED06958949901084 EUDAMED06958949901077 EUDAMED06958949908052 EUDAMED
- Basic UDI-DI
- B-06958949908045 EUDAMEDB-06958949901084 EUDAMEDB-06958949901077 EUDAMEDB-06958949908052 EUDAMED
- EMDN Code
- Z12030302 SYRINGE PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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 Hunan Beyond Medical Technology 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-06958949908045 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hunan Beyond Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002143
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (4)
- EUDAMED b3710cc5-40a2-4ebb-a312-5bd5e87b558d 61 fields · synced Jul 14, 2026
- EUDAMED f7337d41-4ee6-453d-a162-a039711cd44d 61 fields · synced May 18, 2026
- EUDAMED 74b5d625-c0b1-4750-98f2-84a6f992687d 61 fields · synced May 18, 2026
- EUDAMED 60bc5b28-9fcb-4712-83b9-8448f0d3d13e 61 fields · synced May 19, 2026