- Role
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- Date of registration
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US-MF-000025565TCS Fresh Dental Appliance Cleaner Box/24 packets is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Thermoplastic Comfort Systems, Inc.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 27, 2026
++D8054505ZMPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
+D8054505020
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
1 warning recorded — scroll inside the panel to see all entries.
Do not put powder or solution in mouth. Rinse well.Contains persulfates which may cause allergic reaction. If you experience irritation due to cleaner, discontinue use and consult a healthcare professional. In case of accidental ingestion, contact a Poison Control Center. Keep out of reach of children. Not recommended for use on prosthetics fabricated with Ticonium Alloy.
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 Romania; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | 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.
+D8054505020Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
++D8054505ZM4505-02UDI 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.
Q010280PROSTHETIC DENTISTRY DEVICES - ACCESSORIES++D805TCSRESINSS8On the marketKaradent by TCS++D805TCSRESINSS8On the marketKaradent by TCS++D805TCSRESINSS8On the marketTCS Fresh Dental Appliance Cleaner Envelope for Individual Packet++D8054505ZMOn the marketUnbreakable by TCS++D805TCSRESINSS8On the marketUnbreakable by TCS++D805TCSRESINSS8On the marketNo certificate specifically references this device's Basic UDI-DI.
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.