SARMED SRL

FDA Device Registration & Listing · IGLESIAS Sardegna, IT · Registration 3005695808

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005695808
FEI Number
3005695808
Entity Name
SARMED SRL
City/State/Country
IGLESIAS Sardegna, IT
Establishment Address
via Centauro 24, IGLESIAS Sardegna 09016, IT
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
SARMED SRL (Owner Number: 9086224)
Owner / Operator Contact Address
LOCALITA SA STOIA, --, IGLESIAS, IT-NOTA 09016, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Purema H Hemoconcentrators (EtO sterilized) H2H Substitution Filter H2H Water Filter OLpur MD220 Hemodiafiltration Filter H2H Infusion Set Nephros On-Line Mid-Dilution Hemodiafiltration System H2H Rinse Line Renaflo II Hemofilter - 400-700-1200 Hemocor HP Hemoconcentrator - HP700 + TS DSU-H Ultrafilter SSU-H Ultrafilter Hydraguard 10" Ultrafilter - Flushable Hydraguard 10" Ultrafilter Hydraguard 10" Uktrafilter - Flushable FiberFlo Hollow Fiber Cartridge Water Filter S100 - Sink Spout S100 - Handheld Thread S100 POInt Of Use Filter S100 - Sink Spray S100 Handheld Quick Connect SSU-D MSU SSU Mini JG SSU- Mini DSU-D Renaflo II Hemofilter - HF 2000 Hemocor HP Hemoconcentrators - 400-1000-1400 + TS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-12-11
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2016-12-16
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-04-28
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-04-28
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2016-12-16
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2025-08-01
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-02-25
NHV System, Water Purification, General Medical Use Gastroenterology, Urology Class 2 876.5665 2016-12-20
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2016-12-16
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-04-28
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-04-28

Official Correspondent

No official correspondent registered.

US Agent Details

Greg Collins Business: Medica USA Inc. Email: greg.collins@medica-spa.com Phone: (952) 6005733

Related Public Records

Same Entity

SARMED SRL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K811830 Cordis Corp. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 1981-09-21
K070320 Edwards Lifesciences Services GmbH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 2007-06-07
K150880 Outset Medical Tablo Console with Wireless Capability 2015-05-01
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0019-2025 Outset Medical, Inc. 2
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis SYS, with CDX
Z-0029-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System without CDX
Z-0030-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System w/Bibag
Z-0031-2024 Fresenius Medical Care Holdings, Inc. 2
2008T GEN 2 Bibag without CDX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005695808. Last updated year: 2026. Please use registration number 3005695808 when referencing this establishment in official correspondence.
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