Identity
- Trade Name
- Tourniquet Sleeve 25 - 32 cm EUDAMEDTourniquet Sleeve FDA UDI
- Generic Name
- Tourniquet cuff bandage, non-latex FDA UDI
- Device Name
- Tourniquet Consumables - Sleeve sterile EUDAMED25 - 32 cm FDA UDI
- Model / Reference
- 23-00-711-1 EUDAMEDFDA UDI
- Description
- 25 - 32 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250105618846 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-3.3.4-s-PY EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff bandage, non-latex 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
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
Dimensions & Sizes
- Size
- Length — 35 Centimeter FDA UDI
Category: Tourniquet cuff, single-use
Tourniquet Sleeve 25 - 32 cm by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tourniquet cuff, single-use.
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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 | 42501056-3.3.4-s-PY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VBM Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000005907
Sources (2)
- EUDAMED 264a9cf7-411c-4178-96a2-c7e171aa8e96 61 fields · synced Jul 9, 2026
- FDA UDI 9f23fb2d-93bc-40ae-9d07-b7de0eb3e37e 36 fields · synced May 30, 2026