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EUDAMED last updated this device on Dec 2, 2025
37004836Speculums1WXADJUSTABLE SPECULUM 17MM - TEMPORAL FIT is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Moria S.A.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
FR-MF-000000336(01)03700483629602
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 France; available across 1 country total.
Placed on the market in France; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
03700483629602Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
37004836Speculums1WX20054UDI 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.
Q0299OPHTHALMIC DEVICES - 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 →37004836Speculums1WXOn the marketADJUSTABLE COLIBRI SPECULUM CW37004836Speculums1WXOn the marketAdjustable plast. speculum37004836Speculums2WZOn the marketADJUSTABLE SPECULUM 17MM- NASAL FIT37004836Speculums1WXOn the marketALTK applanator lense 6-8-1037004836lensesL7On the marketALTK applanator lense 7-9-1137004836lensesL7On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
39713SupplementedNotified 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 →