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-009 EUDAMEDSingle-use Sterile Tourniquet Cuff - Leg - Conical FDA UDI
Identifiers
- Catalog Number
- 40868 FDA UDI
- Primary DI / UDI-DI
- 06975218190314 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 447b57b5-5dfe-423c-96e3-77e898e142cc 61 fields · synced Oct 6, 2026
- FDA UDI f1d5c812-bc94-4a9d-a29b-c1881aab6a8a 33 fields · synced May 30, 2026