Identity
- Device Name
- Disposable infusion pump EUDAMED
- Model / Reference
- 0527500800126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973740676412 EUDAMED
- Basic UDI-DI
- 697374067SZB-002WC EUDAMED
- Direct Marketing DI
- 06973740676412 EUDAMED
- EMDN Code
- A05010201 ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable infusion pump by Zhejiang Runqiang Medical Instruments Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697374067SZB-002WC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Runqiang Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000005693
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 94043a2d-07d4-433a-a3fe-4e4e46b05067 61 fields · synced Jun 17, 2026