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InfuseIT 500 ml Disposable Pressure Infusor
EUDAMEDClass IIa (EU MDR)
Ref ZIT-520-10Model InfuseIT Pressure Infusor
by Salter Labs
Identity
- Trade Name
- InfuseIT 500 ml Disposable Pressure Infusor EUDAMED
- Model / Reference
- InfuseIT Pressure Infusor EUDAMEDZIT-520-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20607411913406 EUDAMED
- Basic UDI-DI
- 0607411TF20012a_PIB9F EUDAMED
- Unit of Use DI
- 00607411913402 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 500 ml Disposable Pressure Infusor by Salter Labs, LLC — 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 de8d4957-a776-463d-a03e-d21117bba6d3 61 fields · synced Oct 6, 2026