Sterile Single-use Tourniquet Cuff
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Sterile Single-use Tourniquet Cuff EUDAMEDN/A FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- Sterile Single-use Tourniquet Cuff EUDAMEDSTERILE DISPOSABLE TOURNIQUET CUFF,SINGLE PORT, SINGLE BLADDER, SIZE L, 34 IN FDA UDI
- Model / Reference
- VTS-117(XXL) EUDAMEDL FDA UDI
- Description
- STERILE DISPOSABLE TOURNIQUET CUFF,SINGLE PORT, SINGLE BLADDER, SIZE L, 34 IN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 96973521872777 EUDAMEDFDA UDI
- Basic UDI-DI
- 697352187DSTQSRG EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 34 Inch FDA UDI
Category: Tourniquet cuff, single-use
Sterile Single-use Tourniquet Cuff by Vistar Medical Supplies Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tourniquet cuff, single-use.
- Disposable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Sterile Disposable Contour Cuff — Delfi Medical Innovations Inc · Class I
- Tourniquet cuff — NINGBO ZHUOQIU MEDICAL EQUIPMENT CO., LTD. · Class I
- Pneumatic Tourniquet Cuff — Tiantai Typhung Medical Supplies Co., Ltd · Class I
- Cuissard garrot autoclavable conique adulte XL 12x90cm DDM — SPENGLER SAS · Class I
- TMT Rigid Holster Kit w/ Malice Clip Tactical Taylor Back Attachment — SAFEGUARD US OPERATING, LLC · Class I
- Mobile Stand for Tourniquet — VBM Medizintechnik GmbH · Class I
- Disposable cuff 2XL, standard connector, 10 pcs. — ATMOS MedizinTechnik GmbH & Co. KG · 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 | 697352187DSTQSRG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vistar Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000011207
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED ca4ad1fc-25a3-4184-9c9b-55e355523185 61 fields · synced Jul 21, 2026
- FDA UDI bcecef18-1151-4707-a173-afd9eb13b211 34 fields · synced May 30, 2026