- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 4, 2024
880954820WELT-i-AJJWELT-i-A is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by WELT Corp.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08809548200055WELT-iP-A (01)08809548200055
European Medical Device Nomenclature — the EU product classification assigned to this device.
V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES1 warning recorded — scroll inside the panel to see all entries.
1 For those with a co-existing (comorbid) disease of a severe or higher severity or an illness that may get worse due to sleep restriction, an adequate consultation with a doctor is required before use. 2 The product is not intended to replace drugs. 3 The product contains sensitive medical information. A security measure needs to be taken, e.g., a smart phone lock to block access by others. In case of an accident related to cyber security, contact and report it through the manufacturer’s emergency number (+82-2-6439-0707) and wait for a manager to take an action. 4 It is recommended that the operating environment for using the product 5 There is no unacceptable risk in using this product, but to protect the product and personal information, we recommend updating security devices (installation of anti-virus, etc.) on your smartphone.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
KR-MF-000040293Sterile
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.