- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 11, 2026
8437009065000010017WSaline Steridose 30 x 10 mL is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Unolab manufacturing, S.L.. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08437009065129PSU-00191 packaging level registered — each level carries its own UDI-DI.
08437009065129× 1 unitBase unit18437009065126× 30 unitsES-MF-000000272(01)08437009065129
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
10 warnings recorded — scroll inside the panel to see all entries.
OTHER
OTHER
OTHER
OTHER
OTHER
OTHER
OTHER
OTHER
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 Sweden; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Jun 11, 2026 | Still on market |
| Austria | Jun 11, 2026 | Still on market |
| Germany | Jun 11, 2026 | Still on market |
| Denmark | Jun 11, 2026 | Still on market |
| Finland | Jun 11, 2026 | Still on market |
| Iceland | Jun 11, 2026 | Still on market |
| Netherlands | Jun 11, 2026 | Still on market |
| Norway | Jun 11, 2026 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q02030206EYE LUBRICANT SOLUTIONSPrimary 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-0200400414SKOn the marketFisiocare Fiale Eurospital 20 x 2 mL8437009065000010017WOn the marketIEA Medical Augentropfen 0.1% HA 20 x 0.4 mL8437009065001030018ROn the marketSanavita Collirio +day Monodose 10 x 0.4 mL8437009065001030018ROn the marketSpectrum Saline Isotonic Buffered Saline Solution 100 x 5 mLB-8437009065001020028LFCOn the marketVidi Pharma Baby Saltvannsdråper 20 x 5 mL8437009065000010017WOn the marketCertificate health across this manufacturer's portfolio.
2024 CR 0040IssuedNotified 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 →