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Hand Inflator for Roll-On Cuff 200 mmHg
EUDAMEDFDA UDIClass I (EU MDR)
Ref 21-95-300
Identity
- Trade Name
- Hand Inflator for Roll-On Cuff 200 mmHg EUDAMEDn.a. FDA UDI
- Generic Name
- Tourniquet cuff, reusable FDA UDI
- Device Name
- Tourniquet Consumables - Acc. TQ Consumables EUDAMEDHand Inflator for Roll-On Cuff FDA UDI
- Model / Reference
- 21-95-300 EUDAMEDFDA UDI
- Description
- Hand Inflator for Roll-On Cuff FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14250105607182 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-3.3.7-WH EUDAMED
- Direct Marketing DI
- 04250105607185 EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff, reusable 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tourniquet cuff, single-use
Hand Inflator for Roll-On Cuff 200 mmHg by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 42501056-3.3.7-WH | 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 c9d2825f-01d9-40d6-bcdb-dc5354724edc 61 fields · synced Jul 13, 2026
- FDA UDI c7afcc63-31ba-499e-8b97-7c7dac7a1f48 35 fields · synced May 30, 2026