Identity
- Trade Name
- Infusion pump EUDAMED
- Device Name
- Infusion pump EUDAMED
- Model / Reference
- INFU-Z 2000 EUDAMEDINFU-Z 1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809417422076 EUDAMED08809417422014 EUDAMED
- Basic UDI-DI
- B-08809417422076 EUDAMEDB-08809417422014 EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion pump by Zerone 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-08809417422076 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zerone Co., Ltd.
- EUDAMED SRN
- KR-MF-000014148
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 2dc23d90-0dd2-4286-beda-ee3cb28a0bed 61 fields · synced Jul 12, 2026
- EUDAMED 211fde6a-d9e3-4a6e-88f5-4e69f43a5a29 61 fields · synced May 17, 2026