- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 27, 2026
871850376INS001H4InsuJet™ Starter Pack V5 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by European Pharma Group B.V.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08718503764542SIN003E1NL-MF-000021390(01)08718503764542
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
4 warnings recorded — scroll inside the panel to see all entries.
CW010CW007CW011CW262Sterile
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 Spain; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Mar 20, 2024 | Still on market |
| Poland | Mar 20, 2024 | Still on market |
| Portugal | Mar 20, 2024 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHERPrimary 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.
B-08718503763842On the marketInsuJet™ Starter Pack V5B-08718503764627On the marketInsuJet™ Starter Pack V5B-08718503762715On the marketInsuJet™ V5 Kit de InceputB-08718503763880On the marketInsuJet™ V5 Kit de Inceput871850376INS001H4On the marketnsuJet™ 3 ml-es Adapter871850376ADA0016GOn the marketNo 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.