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Disposable infusion pump
EUDAMEDClass IIb (EU MDR)
Ref E06000200117Model SZB-CX-F 60mL/2mL/h
Identity
- Trade Name
- Disposable infusion pump EUDAMED
- Model / Reference
- SZB-CX-F 60mL/2mL/h EUDAMEDE06000200117 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16952803712028 EUDAMED
- Basic UDI-DI
- B-16952803712028 EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Disposable infusion pump by Zhejiang Fert Medical Device 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-16952803712028 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Fert Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000012602
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d0d78053-952b-4cd1-ab69-49a15789a2a4 61 fields · synced Oct 5, 2026