Tourniquet Drape - Tourniquet Drape
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Tourniquet Drape; large ≥ 40 - 80 cm EUDAMEDTourniquet Drape; large FDA UDI
- Generic Name
- Tourniquet cuff, single-use FDA UDI
- Device Name
- Tourniquet Consumables - Drape non-sterile EUDAMED40 - 80 cm FDA UDI
- Model / Reference
- 24-00-200 EUDAMEDFDA UDI
- Description
- 40 - 80 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250105630282 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-3.3.3-n-PA EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- Z12139006 PNEUMATIC TOURNIQUETS EUDAMED
- GMDN Term
- Tourniquet cuff, single-use FDA UDI
- Models / Variants
- Tourniquet Drape 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Tourniquet cuff, single-use
Tourniquet Drape - Tourniquet Drape 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.
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- Disposable cuff 2XL, standard connector, 10 pcs. — ATMOS MedizinTechnik GmbH & Co. KG · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42501056-3.3.3-n-PA | 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 5075589f-17cd-42c2-84b0-de61bcec66ee 61 fields · synced Jun 18, 2026
- FDA UDI bf0b2249-74ac-477e-be4e-cab1093d14c8 35 fields · synced May 30, 2026