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Sterile Exsanguination Tourniquets
EUDAMEDClass I (EU MDR)
Ref QXH-060-OR-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-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-060-OR-01A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922504240093 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 — CE/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 (1)
- EUDAMED da703812-e361-41d4-91dd-11bbff516b20 61 fields · synced Oct 6, 2026