- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Sep 7, 2026
4262585284fixation99DE-MF-000052853Formaldehyde solution 4% buffered is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by LM4med GmbH. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →(01)04262585280116
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.
Primary placement in Sweden; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| SwedenPrimary placement | Aug 31, 2026 | Still on market |
| Denmark | Aug 31, 2026 | Still on market |
| Finland | Aug 31, 2026 | Still on market |
| Norway | Aug 31, 2026 | 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.
04262585280116Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4262585284fixation99LM-02166UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
1 packaging level registered — each level carries its own UDI-DI.
04262585280116× 1 unitBase unit04262585280314× 18 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)No 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.4262585284fixation99On the marketFormaldehyde solution 4% buffered4262585284fixation99On the marketFormaldehyde solution 4% buffered4262585284fixation99On the marketFormaldehyde solution 4% buffered4262585284fixation99On the marketFormaldehyde solution 4% buffered4262585284fixation99On the marketFormaldehyde solution 4% buffered4262585284fixation99On the marketNo certificate specifically references this device's Basic UDI-DI.