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InfuseIT™ 500ml Reusable Pressure Infusor
EUDAMEDClass IIa (EU MDR)
Ref ZIT-520-5 Model InfuseIT Pressure Infusor
by Salter Labs
Identity
- Trade Name
- InfuseIT™ 500ml Reusable Pressure Infusor EUDAMED
- Model / Reference
- InfuseIT Pressure Infusor EUDAMEDZIT-520-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10607411916912 EUDAMED
- Basic UDI-DI
- 0607411TF20012a_PIB9F EUDAMED
- Unit of Use DI
- 00607411916915 EUDAMED
- EMDN Code
- A0599 MECHANICAL INFUSION SYSTEMS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
InfuseIT™ 500ml Reusable Pressure Infusor by Salter Labs — 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 | 0607411TF20012a_PIB9F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Salter Labs
- EUDAMED SRN
- US-MF-000007934
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 4e7aaa42-b229-4120-b8e6-f58e66901c17 61 fields · synced Jul 18, 2026