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Thd Bandy
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 800183Model THD BANDY
by Thd S.p.a.
Identity
- Trade Name
- THD BANDY EUDAMEDFDA UDI
- Generic Name
- Haemorrhoid ligation set FDA UDI
- Device Name
- THD BANDY EUDAMEDTHD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single use), including ligator and loading system. THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger FDA UDI
- Model / Reference
- THD BANDY EUDAMEDFDA UDI800183 EUDAMED
- Description
- THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single use), including ligator and loading system. THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger FDA UDI
Identifiers
- Catalog Number
- 800183 FDA UDI
- Primary DI / UDI-DI
- 08033737712153 EUDAMEDFDA UDI
- Basic UDI-DI
- 803373771BAN000135 EUDAMED
- 510(k) Number
- K093497 FDA UDI
- FDA Product Code
- FHN FDA UDI
- EMDN Code
- G020401 HAEMORRHOID LIGATURE SETS EUDAMED
- GMDN Term
- Haemorrhoid ligation set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 154 Millimeter FDA UDIOuter Diameter — 12.8 Millimeter FDA UDI
Thd Bandy by Thd S.p.a. — Class IIa — 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 | 803373771BAN000135 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Thd S.p.a.
- EUDAMED SRN
- IT-MF-000029427
Sources (2)
- EUDAMED e7439efa-4a41-46f3-b825-27a76c0bade5 61 fields · synced Jun 1, 2026
- FDA UDI 62aed90d-66b6-46ed-b9e1-f87439f9e813 37 fields · synced May 30, 2026