Identity
- Trade Name
- Cuff Cover; large 58-81 cm EUDAMEDCuff Cover FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- Tourniquet Consumables - Cuff Cover EUDAMEDlarge, 58 - 81 cm FDA UDI
- Model / Reference
- 20-11-222-1 EUDAMEDFDA UDI
- Description
- large, 58 - 81 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250105629651 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-3.3.5-s-Q7 EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff, single-use FDA UDI
- Models / Variants
- Cuff Cover EUDAMEDFDA 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Tourniquet cuff, single-use
Cuff Cover - Cuff Cover by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 2 models — 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
- Tourniquet Cuff — Vistar Medical Supplies 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
- Disposable cuff 2XL, standard connector, 10 pcs. — ATMOS MedizinTechnik GmbH & Co. KG · Class I
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 | 42501056-3.3.5-s-Q7 | 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
- VBM Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000005907
Sources (2)
- EUDAMED b4135537-5027-4c5c-b99b-4f85232de35e 61 fields · synced Sep 18, 2026
- FDA UDI d501ede5-5f15-485c-80f5-3a7bdc5aa198 35 fields · synced May 30, 2026