Identity
- Trade Name
- tourniquet EUDAMED
- Device Name
- Tourniquet EUDAMED
- Model / Reference
- 1401013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454708407 EUDAMED
- Basic UDI-DI
- 69514547318VH EUDAMED
- EMDN Code
- C90010301 HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
tourniquet by Gauke Healthcare Co., Ltd — Class I — CE/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 | 69514547318VH | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED d8a289ed-1846-4dc8-bbcb-6424e07970c9 61 fields · synced Oct 7, 2026