- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 9, 2024
B-06941784101351Nitinol (NiTi) Orthodontic Wires is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Beijing Smart Technology Co., Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06941784101351SM-RC-R-1625-UCN-MF-000015988DD 60152743 0001(01)06941784101351
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 Italy; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jan 1, 2022 | Dec 31, 2027 |
| France | Jan 1, 2022 | Dec 31, 2027 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010405ORTHODONTIC WIRESPrimary 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-06941784103812On the marketNitinol (NiTi) Orthodontic Wires69417841NTWIRE56On the marketNitinol (NiTi) Orthodontic WiresB-06941784100477On the marketNitinol (NiTi) Orthodontic WiresB-06941784100743On the marketNitinol (NiTi) Orthodontic WiresB-06941784101368On the marketNitinol (NiTi) Orthodontic WiresB-06941784100491On the marketNo 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.