Identity
- Device Name
- De Bakey Harken Auricle Clamp, 240mm EUDAMED
- Model / Reference
- CS5-2044-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391551752094 EUDAMED
- Basic UDI-DI
- 539155175CS5-2044-24Y4 EUDAMED
- EMDN Code
- L080599 THORACIC SURGERY CLAMPS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
De Bakey Harken Auricle Clamp, 240mm by Cardio Surgical Ltd. — 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 | 539155175CS5-2044-24Y4 | Class I | Active |
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Manufacturer
- Manufacturer
- Cardio Surgical Ltd.
- EUDAMED SRN
- IE-MF-000011150
Sources (1)
- EUDAMED b657dc49-b9dc-4845-8b2b-edca550e4b75 61 fields · synced Jun 17, 2026