- Role
- Country
- Date of registration
- Address
IT-MF-000027856561-00-00-DMSterile swabs with plastic shaft, viscose tip and Amies with coal transport medium is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by SYNTESYS S.R.L.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 23, 2026
B-08054141491908Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08054141491908
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jun 9, 2022 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08054141491908Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-08054141491908382291UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
A1102SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUMNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-08054141491892On the marketSterile swabs with plastic shaft and viscose tip, with Amies transport mediumB-08054141491885On the marketSterile swabs with plastic shaft and viscose tip, with Stuart transport mediumB-08054141491915On the marketSterile wooden swab with cotton tip in tubeB-08054141491922On the marketSterilizable polypropylene bed pan individually wrapped805414149PADELLAECOn the marketSterilizable polypropylene bed pan with folded handle individually wrapped805414149PADELLAECOn the marketNo certificate specifically references this device's Basic UDI-DI.