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ITL EssentialsTM Tourniquet B&B Thick Strap 45cm NS
EUDAMEDFDA UDIClass I (EU MDR)
Ref A600001
Identity
- Trade Name
- ITL EssentialsTM Tourniquet B&B Thick Strap 45cm NS EUDAMEDITL Essentials™ Tourniquet B&B Thick Strap 45cm NS FDA UDI
- Generic Name
- Venous tourniquet, reusable FDA UDI
- Device Name
- Tourniquet EUDAMEDThe tourniquet is a constricting band used to control venous and arterial circulation to an extremity for a period of time. The device is for single patient use only. FDA UDI
- Model / Reference
- A600001 EUDAMEDFDA UDI
- Description
- The tourniquet is a constricting band used to control venous and arterial circulation to an extremity for a period of time. The device is for single patient use only. FDA UDI
Identifiers
- Catalog Number
- A600001 FDA UDI
- Primary DI / UDI-DI
- 19555240404098 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040TOUNSMN EUDAMED
- FDA Product Code
- GAX FDA UDI
- EMDN Code
- V9003 TOURNIQUETS EUDAMED
- GMDN Term
- Venous tourniquet, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5900 FDA UDI
- 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: Limb tourniquet, manual, reusable
ITL EssentialsTM Tourniquet B&B Thick Strap 45cm NS by Itl Asia Pacific Sdn. Bhd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Limb tourniquet, manual, reusable.
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- TOURNIQUET — ZHENGZHOU MEDCONS IMPORT&EXPORT TRADING CO.,LTD · Class I
- garrot militaire combat application toueniquet — Danyang Sunmed Healthcare Corporation · Class I
- Constricting band — EMSRUN GROUP · Class I
- 200 Single use tourniquets InControl brand — ASEP HEALTHCARE LTD · 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 | 955524040TOUNSMN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 27184531-a99f-4ec5-839e-21572582d0c7 61 fields · synced Jun 18, 2026
- FDA UDI 6231eaee-6b29-4345-bef5-8c18e5e2856d 36 fields · synced May 30, 2026