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Sterile Exsanguination Tourniquets
EUDAMEDClass I (EU MDR)
Ref QXH-028-PI-01AModel QXH-028-PI-01A, QXH-040-GR-01A, QXH-040-RE-01A, QXH-040-YE-01A, QXH-060-BL-01A, QXH-060-OR-01A, QXH-060-BR-01A, QXH-090-BW-01ARef QXH-040-RE-01ARef QXH-060-OR-01ARef QXH-060-BL-01ARef QXH-090-BW-01A
Identity
- Trade Name
- Sterile Exsanguination Tourniquets EUDAMED
- Model / Reference
- QXH-028-PI-01A, QXH-040-GR-01A, QXH-040-RE-01A, QXH-040-YE-01A, QXH-060-BL-01A, QXH-060-OR-01A, QXH-060-BR-01A, QXH-090-BW-01A EUDAMEDQXH-028-PI-01A EUDAMEDQXH-040-RE-01A EUDAMEDQXH-060-OR-01A EUDAMEDQXH-060-BL-01A EUDAMEDQXH-090-BW-01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922504240031 EUDAMED06922504240055 EUDAMED06922504240093 EUDAMED06922504240079 EUDAMED06922504240109 EUDAMED
- Basic UDI-DI
- 6922504QXHHS EUDAMED
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Limb tourniquet, manual, reusable
Sterile Exsanguination Tourniquets by Shandong Bainus Medical Instrument 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 | 6922504QXHHS | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Bainus Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001120
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED f2121153-f129-4a2d-aefc-9a512c5b070b 61 fields · synced Sep 17, 2026
- EUDAMED 3614384b-e5b5-4447-b1d5-be5872e76771 61 fields · synced May 17, 2026
- EUDAMED da703812-e361-41d4-91dd-11bbff516b20 61 fields · synced May 17, 2026
- EUDAMED 31d24222-92d0-46d2-8a5b-be757d317bd1 61 fields · synced May 17, 2026
- EUDAMED 87d28913-589c-4eb9-900b-bddc69222f69 61 fields · synced May 18, 2026