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EUDAMED last updated this device on Jun 23, 2026
B-08054141491885Sterile swabs with plastic shaft and viscose tip, with Amies 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.
IT-MF-000027856561-00-00-DM(01)08054141491885
1 warning recorded — scroll inside the panel to see all entries.
Not suitable for any other application than its intended use. Do not use if the packaging has any signs of breakage or damage. If you see that the unit package has lost its integrity, do not use the swab as there is no guarantee of its sterility. Do not use if you notice that the swab is dirty. Discard the product if you find any broken brushes, with edges or without a head. Do not use if the liquid of the transport swab with media is cloudy or seems altered. Only for single use, the reuse of this product may cause infections. Handle carefully. Any strong pressure during use, although unlikely, could break the swab. In the case of any damage, discard immediately. After use, the swabs must be decontaminated or treated as contaminated medical waste. It is the responsibility of each laboratory to handle, treat and dispose the waste according to the current legislation. Unused swabs can be considered non-hazardous products and can be disposed of accordingly. All the above is applicable to the enrichment media supplied with flocked swab. Do not use if the expiration date has been exceeded. Do not use if any component is missing or if the printed product information is not displayed correctly. Do not ingest the means of transport under any circumstances.
Sterile
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.
08054141491885Basic 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-08054141491885382201UDI 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 MEDIUMPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
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No 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.