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Tourniquet
EUDAMEDClass I (EU MDR)
Ref 318Ref 1401013Ref /Ref REF MDLE-01Ref REF 318 Ref 110-202508Ref 1401012Ref ENTOT51Ref 1401014
Identity
- Trade Name
- Tourniquet EUDAMEDTourniquet 6cmx125cm EUDAMED
- Device Name
- Tourniquet EUDAMED
- Model / Reference
- 318 EUDAMED1401013 EUDAMED/ EUDAMEDREF MDLE-01 EUDAMEDREF 318 EUDAMED110-202508 EUDAMED1401012 EUDAMEDENTOT51 EUDAMED1401014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454702276 EUDAMED06951454708407 EUDAMED06951454784159 EUDAMED06951454768500 EUDAMED06951454778400 EUDAMED06951454734840 EUDAMED06951454702139 EUDAMED06951454734826 EUDAMED06951454768456 EUDAMED06951454772880 EUDAMED06951454707394 EUDAMED
- Basic UDI-DI
- 69514547318VH EUDAMED
- EMDN Code
- V9003 TOURNIQUETS EUDAMEDC90010301 HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDGreece EUDAMEDItaly EUDAMEDCzechia EUDAMEDGermany EUDAMEDBulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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: Limb tourniquet, manual, reusable
Tourniquet by Gauke Healthcare Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Limb tourniquet, manual, 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 | 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 (11)
- EUDAMED 85c6b21f-5193-4cca-be32-9100b4cc12b6 61 fields · synced Oct 6, 2026
- EUDAMED d8a289ed-1846-4dc8-bbcb-6424e07970c9 61 fields · synced May 11, 2026
- EUDAMED d6fe76ae-c969-4ac3-807e-8ae478ddbb5f 61 fields · synced May 16, 2026
- EUDAMED cafdc452-8010-44cc-9059-25d95d590d53 61 fields · synced May 16, 2026
- EUDAMED 3c61de0a-6d6f-4608-80db-9f029194b6e4 61 fields · synced May 17, 2026
- EUDAMED c7894348-8402-4be7-ba4d-f3d0f642dfb8 61 fields · synced May 17, 2026
- EUDAMED 23968170-b1c3-417d-9914-dce01745bb80 61 fields · synced May 17, 2026
- EUDAMED 99c36157-b8f7-4f1b-aa9a-e6384fa81029 61 fields · synced May 18, 2026
- EUDAMED 7ec8d4aa-a479-4da6-add3-f20b1abfddae 61 fields · synced May 19, 2026
- EUDAMED f544a30b-fe76-40cc-b572-87311f2f3fa8 61 fields · synced Jul 9, 2026
- EUDAMED c5c40a62-7710-4147-9ae3-2ab343444395 61 fields · synced Jul 15, 2026