Tourny™ + Tourniquets
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Batrik Tourny, 1x 18", Green, Non-sterile FDA UDI
- Generic Name
- Limb tourniquet, manual, single-use FDA UDI
- Device Name
- TOURNY™ + TOURNIQUETS EUDAMEDTourny Green L/Free Tourn/.18" Roll FDA UDI
- Model / Reference
- 910-1000-100 EUDAMEDK-3-18RL EUDAMEDFDA UDI
- Description
- Tourny Green L/Free Tourn/.18" Roll FDA UDI
Identifiers
- Catalog Number
- K-3-18RL FDA UDI
- Primary DI / UDI-DI
- 00690521020801 EUDAMED00690521011878 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210TOURNY1000G3 EUDAMED
- FDA Product Code
- GAX FDA UDI
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
- GMDN Term
- Limb tourniquet, manual, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Limb tourniquet, manual, reusable
Tourny™ + Tourniquets by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Limb tourniquet, manual, reusable.
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- TOURNIQUET — ZHENGZHOU MEDCONS IMPORT&EXPORT TRADING CO.,LTD · Class I
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- Constricting band — EMSRUN GROUP · Class I
- 200 Single use tourniquets InControl brand — ASEP HEALTHCARE LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210TOURNY1000G3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED f053b833-b1ee-4422-9fd5-40aae1b6127f 61 fields · synced Aug 3, 2026
- EUDAMED 9ef386fe-ecea-43d1-b30a-3d7dc11213ea 61 fields · synced May 19, 2026
- FDA UDI 2be82b53-c3d8-492a-9ef1-fec2f8c84c54 36 fields · synced May 30, 2026