- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Sep 15, 2026
376043228ArthaDMFSArthaDepthMappingV1.apk is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by SEEHAPTIC. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
37604322800870ArthaDepthMappingV1.apk(01)37604322800870
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y214224AUGMENTATIVE SOFTWARE7 warnings recorded — scroll inside the panel to see all entries.
OTHER
OTHER
OTHER
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Sep 15, 2026 | Still on market |
FR-MF-000057323OTHER
SeeHapticDM doit être utilisé uniquement par des utilisateurs formés SeeHapticDM doit être utilisé avec une aide à la mobilité primaire, comme une canne blanche (non vibrante) ou un chien guide En cas de divergence entre la carte de profondeur et l'aide primaire, TOUJOURS se fier à l'aide primaire Chaque utilisation de SeeHapticDM doit être anticipée par l'utilisateur avec une préparation du trajet, comme ce serait le cas avec une canne blanche
Si vous constatez un changement soudain dans votre déficience visuelle ou vos capacités cognitives ou de mobilité, veuillez envisager une formation supplémentaire avant d'utiliser à nouveau l'appareil et consulter un professionnel de la santé
Qui ne doit pas utiliser ce dispositif ? ● les personnes de moins de 18 ans ; ● les femmes enceintes ; ● les personnes présentant des capacités sensorielles tactiles, cognitives ou motrices altérées → ces capacités seront évaluées lors de la prise en main (onboarding), avant la remise du dispositif, par un professionnel de santé ; ● les personnes souffrant de dépression.
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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.
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.