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EUDAMED last updated this device on Jul 18, 2022
697271269BT902BT972KZWHEELCHAIR is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Better medical technology Co.,Ltd. Placed on the EU market in Croatia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06972712690104BT972(01)06972712690104
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y122199WHEELCHAIRS - OTHERPrimary placement in Croatia; available across 1 country total.
Placed on the market in Croatia; per-country availability dates not published.
CN-MF-000001280The 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.
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.
697271269BT301BT306EPOn the marketROLLATOR697271269BT801BT855JUOn the marketShower Bed697271269BT612G2On the marketBT682A BT682B BT680-B697271269BT682ABT682B13HBOn the marketBT-CU13,BT-CU17,BT-CU206972712696972712690524BAOn the marketBT310A ,BT681E-500,BT681E-500/700697271269BT310BT681FQOn 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.