- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Apr 17, 2023
5604425SSPFFPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →FJ 490L 1PD (70*70*100) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by PROHS Equipamento Hospitalar e Serviços Associados S.A.. Placed on the EU market in Portugal. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →05604425000802Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →5604425SSPFFFJ 490L 1PD (70*70*100)UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →(01)05604425000802
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12011304AUTOCLAVES WITH A CHAMBER LARGER THAN OR EQUAL TO 1 STANDARD STERILISATION UNITSterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary placement in Portugal; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| PortugalPrimary placement | Still on market | |
| France | Still on market | |
| Poland | Still on market | |
| Romania | Still on market |
PT-MF-000002798Certificate health across this manufacturer's portfolio.
ES23/00000293AmendedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →ES23/00000293B-05604425000000On the marketPROHS Horizontal Steam SterilizerB-05604425001717On the marketPROHS Horizontal Steam SterilizerB-05604425001601On the marketPROHS Horizontal Steam SterilizerB-05604425001908On the marketPROHS Horizontal Steam SterilizerB-05604425002011On the market