- Organization name
- UDI-DI code
- Reference / catalog number
IE-MF-000003108BodiCool Wave Triangle Size 9 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Trulife. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 26, 2024
00643293Breastcare6ZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00643293023853
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 Ireland; available across 19 countries total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Germany | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Lithuania | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00643293023853Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
00643293Breastcare6Z495 09UDI 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.
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHERNo certificate specifically references this device's Basic UDI-DI.
00643293Breastcare6ZOn the marketBodiCool Wave Triangle Size 700643293Breastcare6ZOn the marketBodiCool Wave Triangle Size 800643293Breastcare6ZOn the marketBreastform Cover Left Size 01 (475/ 503)00643293Breastcare6ZOn the marketBreastform Cover Left Size 01 (478/ 482)00643293Breastcare6ZOn the marketBreastform Cover Left Size 02 (475/ 503)00643293Breastcare6ZOn 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.