- Role
- Country
- Date of registration
- Address
US-MF-000010890SOL-M Slip Tip Syringe with Exchangeable Needle is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Sol-Millennium Medical, Inc.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Dec 13, 2024
081006243SN31YTPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00818392012804
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
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 Poland; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Czechia | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Italy | — | Still on market |
| Portugal | — | 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.
00818392012804Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081006243SN31YT181025SUDI 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.
A020102010201INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USECertificate health across this manufacturer's portfolio.
MDR 766495SupplementedNotified 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 →No certificate specifically references this device's Basic UDI-DI.
081006243penneedleKEOn the marketSOL-M Slip Tip Insulin Syringe with Exchangeable Needle081006243INS5ZSOn the marketSOL-M Slip Tip Syringe with Exchangeable Needle081006243SN31YTOn the marketSOL-M Slip Tip Syringe without Needle081006243SR38ZVOn the marketSOL-M Slip Tip Syringe without Needle081006243SR34ZMOn the marketSOL-M Slip Tip Syringe without Needle081006243SR34ZMOn the market