Identity
- Trade Name
- Disposable Infusion Pump EUDAMED
- Device Name
- Disposable Infusion Pump EUDAMED
- Model / Reference
- WZ-6522-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 86938016710548 EUDAMED
- Basic UDI-DI
- B-86938016710548 EUDAMED
- EMDN Code
- A05010201 ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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 Royal Fornia Medical Equipment Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-86938016710548 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-86938016710548 | Class IIb | 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 (1)
- EUDAMED 28314e81-e590-4bd3-9884-9cdd81ab6398 61 fields · synced Oct 6, 2026