Identity
- Device Name
- Gold-Grip De Bakey NDHL P04 20CM EUDAMED
- Model / Reference
- CS2-1021-21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391551750397 EUDAMED
- Basic UDI-DI
- 539155175CS2-1021-21TV EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE 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: Suturing needle holder, reusable
Gold-Grip De Bakey NDHL P04 20CM by Cardio Surgical Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 539155175CS2-1021-21TV | Class I | Active |
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Manufacturer
- Manufacturer
- Cardio Surgical Ltd.
- EUDAMED SRN
- IE-MF-000011150
Sources (1)
- EUDAMED 474e5e09-d792-49d5-abe2-869f2744cd30 61 fields · synced Jun 18, 2026