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Double tip dilator, left tip 7mm, right tip 8mm, total 19cm
EUDAMEDClass I (EU MDR)
Ref CS9-1915-04
Identity
- Device Name
- Double tip dilator, left tip 7mm, right tip 8mm, total 19cm EUDAMED
- Model / Reference
- CS9-1915-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391551754999 EUDAMED
- Basic UDI-DI
- 539155175CS9-1915-0457 EUDAMED
- EMDN Code
- L08060199 THORACIC SURGERY DILATORS, 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
Double tip dilator, left tip 7mm, right tip 8mm, total 19cm 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 | 539155175CS9-1915-0457 | Class I | Active |
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Manufacturer
- Manufacturer
- Cardio Surgical Ltd.
- EUDAMED SRN
- IE-MF-000011150
Sources (1)
- EUDAMED eb9309f4-dd6e-4ed4-87eb-9d4c6357e446 61 fields · synced Jun 18, 2026