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Disposable Infusion Pump
EUDAMEDClass IIa (EU MDR)
Ref WZ-6522-R02Model WZ6522-R
Identity
- Device Name
- Disposable Infusion Pump EUDAMED
- Model / Reference
- WZ6522-R EUDAMEDWZ-6522-R02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938016769502 EUDAMED06938016775602 EUDAMED
- Basic UDI-DI
- 693801670000FU EUDAMED
- EMDN Code
- A05010201 ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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 Royal Fornia Medical Equipment Co., Ltd. — Class IIa — CE/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 | 693801670000FU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Royal Fornia Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008628
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED efd85ced-10ef-4587-88e9-af0c7e12b211 61 fields · synced Oct 6, 2026
- EUDAMED 4a65e30f-9aa2-4f81-b9f9-0c1b633b8ea2 61 fields · synced Jul 9, 2026