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EUDAMED last updated this device on Apr 14, 2026
B-05903999601775DropSafe is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by HTL-Strefa S.A.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
059039996017758432(01)05903999601775
European Medical Device Nomenclature — the EU product classification assigned to this device.
A0101010201HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS1 warning recorded — scroll inside the panel to see all entries.
Keep out of reach of children without adult supervision. ! Avoid infections: Before making an injection, clean and disinfect the injection site. Always follow your facility sharps injury prevention guidelines or local regulations. ! Do not use if the seal or needle is damaged or missing or if the shield or outer cap needle appears to be damaged. ! Refer to the instructions for use of the drug and pen injector device for specific storage and handling instructions.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
PL-MF-00000219884587CE01Sterile
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 DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic 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 →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 →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 →No certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HZ 1023950-1IssuedNotified 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 →