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Infusion Pump
EUDAMEDClass IIb (EU MDR)
Ref Sunfusion Anim-8Ref BYZ-820DRef Sunfusion Semi-2
Identity
- Trade Name
- Infusion Pump EUDAMED
- Device Name
- Infusion Pump EUDAMED
- Model / Reference
- Sunfusion Anim-8 EUDAMEDBYZ-820D EUDAMEDSunfusion Semi-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949909066 EUDAMED06958949902067 EUDAMED06958949909042 EUDAMED
- Basic UDI-DI
- B-06958949909066 EUDAMEDB-06958949902067 EUDAMEDB-06958949909042 EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland 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
No
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion 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-06958949909066 | 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 (3)
- EUDAMED 5c7eb7d8-ef66-49f7-8526-115aab8034c6 61 fields · synced Jul 27, 2026
- EUDAMED e813b77f-50a7-48dd-8339-e6881d49a356 61 fields · synced May 18, 2026
- EUDAMED 415011d4-8757-493e-8545-7c2161abd695 61 fields · synced May 19, 2026