Identity
- Trade Name
- Pneumatic Tourniquet Cuff EUDAMEDTourniquet System FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- Pneumatic Tourniquet Cuff EUDAMED
- Model / Reference
- ZXD-I-005 EUDAMEDSingle-use Sterile Tourniquet Cuff - Large Arm / Small Leg FDA UDI
Identifiers
- Catalog Number
- 40840 FDA UDI
- Primary DI / UDI-DI
- 06975218190291 EUDAMEDFDA UDI
- Basic UDI-DI
- 697521819TF01MA 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Pneumatic Tourniquet Cuff by Tiantai Typhung Medical Supplies Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697521819TF01MA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tiantai Typhung Medical Supplies Co., Ltd
- EUDAMED SRN
- CN-MF-000032892
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 2720c074-e1dd-4abc-92a4-59b22038c166 61 fields · synced Oct 6, 2026
- FDA UDI eb0d4d0f-e468-4975-b5fb-9d15f4944766 33 fields · synced May 30, 2026