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MICS Retractor, BLDs pivot up to 40¡ã, 3x2 exchangeable BLDs
EUDAMEDClass I (EU MDR)
Ref TR100.10
Identity
- Device Name
- MICS Retractor, BLDs pivot up to 40¡ã, 3x2 exchangeable BLDs EUDAMED
- Model / Reference
- TR100.10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391551759277 EUDAMED
- Basic UDI-DI
- 539155175TR100.10FV EUDAMED
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, 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
Category: Hand-held surgical retractor, reusable
MICS Retractor, BLDs pivot up to 40¡ã, 3x2 exchangeable BLDs by Cardio Surgical Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand-held surgical retractor, reusable.
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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 | 539155175TR100.10FV | Class I | Active |
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Manufacturer
- Manufacturer
- Cardio Surgical Ltd.
- EUDAMED SRN
- IE-MF-000011150
Sources (1)
- EUDAMED b0fa1266-cb7d-43ed-baff-e427cb0f033e 61 fields · synced Jun 18, 2026