Identity
- Trade Name
- Roll-On Cuff #2 ; Circumference 26 - 33 cm EUDAMEDn.a. FDA UDI
- Generic Name
- Tourniquet cuff, reusable FDA UDI
- Device Name
- Tourniquet Consumables - Roll-On Cuff EUDAMEDRoll-On Cuff FDA UDI
- Model / Reference
- 21-95-712 EUDAMEDFDA UDI
- Description
- Roll-On Cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250105607246 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-3.3.2-W2 EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff, reusable FDA UDI
- Models / Variants
- Roll-On Cuff #2 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Category: Tourniquet cuff, single-use
Roll-On Cuff #2 - Roll-On Cuff #2 by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 2 models — regulatory data on deviCERTS
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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 | 42501056-3.3.2-W2 | 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 6348c8dc-fc90-4184-b038-6a8b199f39b1 61 fields · synced Jul 9, 2026
- FDA UDI 6078d370-6ac3-40f3-818c-221bf433a5b9 35 fields · synced May 30, 2026