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BodiCool Assymetrical Right Size 3
EUDAMEDClass I (EU MDR)
Ref 497 03RModel Breastcare
by Trulife
Identity
- Trade Name
- BodiCool Assymetrical Right Size 3 EUDAMED
- Device Name
- Breastcare EUDAMED
- Model / Reference
- Breastcare EUDAMED497 03R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00643293025819 EUDAMED
- Basic UDI-DI
- 00643293Breastcare6Z EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BodiCool Assymetrical Right Size 3 by Trulife — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00643293Breastcare6Z | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (1)
- EUDAMED b2f432a5-7c2c-4f6e-bdd2-2cb176afd22d 61 fields · synced Jul 11, 2026