Identity
- Trade Name
- Susol® Digital Tourniquets Large Blue (Pack of 50) FDA UDI
- Generic Name
- Digit tourniquet, manual FDA UDI
- Device Name
- Susol® Digital Tourniquet EUDAMED
- Model / Reference
- S-TQL EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060418833527 EUDAMED05060418834845 FDA UDI
- Basic UDI-DI
- 506041883SSENT3746823 EUDAMED
- Unit of Use DI
- 05060418834845 EUDAMED
- FDA Product Code
- GAX FDA UDI
- EMDN Code
- V901603 SUPERFICIAL TREATMENTS INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Digit tourniquet, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5900 FDA UDI
- Market of Registration
- Northern Ireland 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
Susol® Digital Tourniquet by Bailey Instruments Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 506041883SSENT3746823 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bailey Instruments Ltd.
- EUDAMED SRN
- GB-MF-000013119
- Authorised Representative
- MD REPS Ltd XI-AR-000040375
Sources (2)
- EUDAMED 4e637ee7-346b-4c53-ba19-df302ab4247b 61 fields · synced Jul 18, 2026
- FDA UDI af4c1f33-cca6-4d0a-ba94-6aa5fa81c9c2 32 fields · synced May 30, 2026