- Organization name
- UDI-DI code
- Reference / catalog number
ES-MF-0000247761604/MDDPrimelase is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by High technology Products SLU. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 6, 2026
B-08437020651325Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08437020651325
1 warning recorded — scroll inside the panel to see all entries.
Consult IFU
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 Germany; available across 27 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Dec 16, 2015 | Dec 31, 2028 |
| Austria | Dec 16, 2015 | Dec 31, 2028 |
| Belgium | Dec 16, 2015 | Dec 31, 2028 |
| Bulgaria | Dec 16, 2015 | Dec 31, 2028 |
| Cyprus | Dec 16, 2015 | Dec 31, 2028 |
| Czechia | Dec 16, 2015 | Dec 31, 2028 |
| Denmark | Dec 16, 2015 | Dec 31, 2028 |
| Estonia | Dec 16, 2015 | Dec 31, 2028 |
| EL | Dec 16, 2015 | Dec 31, 2028 |
| Spain | Dec 16, 2015 | Dec 31, 2028 |
| Finland | Dec 16, 2015 | Dec 31, 2028 |
| France | Dec 16, 2015 | Dec 31, 2028 |
| Hungary | Dec 16, 2015 | Dec 31, 2028 |
| Ireland | Dec 16, 2015 | Dec 31, 2028 |
| Iceland | Dec 16, 2015 | Dec 31, 2028 |
| Italy | Dec 16, 2015 | Dec 31, 2028 |
| Liechtenstein | Dec 16, 2015 | Dec 31, 2028 |
| Lithuania | Dec 16, 2015 | Dec 31, 2028 |
| Luxembourg | Dec 16, 2015 | Dec 31, 2028 |
| Malta | Dec 16, 2015 | Dec 31, 2028 |
| Netherlands | Dec 16, 2015 | Dec 31, 2028 |
| Poland | Dec 16, 2015 | Dec 31, 2028 |
| Portugal | Dec 16, 2015 | Dec 31, 2028 |
| Romania | Dec 16, 2015 | Dec 31, 2028 |
| Sweden | Dec 16, 2015 | Dec 31, 2028 |
| Slovenia | — | Dec 31, 2028 |
| Slovakia | Dec 16, 2015 | Dec 31, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08437020651325Basic 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-08437020651325200000366UDI 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.
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHERNo 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.No certificate specifically references this device's Basic UDI-DI.
B-08437020651110On the marketElysion Applicator 510234B-08437020651103On the marketElysion Applicator 510240B-08437020651523On the marketPrimelase Applicator 200001617B-08437020651400On the marketPrimelase Applicator 200001618B-08437020651417On the marketPRIMELASE Applicator 510148B-08437020651509On the market