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Thd Light-Scope Procto Hra
EUDAMEDFDA UDIClass I (EU MDR)
Ref 800191Model THD Not Sterile AnoProctoRectoscopes LED and not LED
by Thd S.p.a.
Identity
- Trade Name
- THD LIGHT-SCOPE PROCTO HRA EUDAMEDTHD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- THD Not Sterile AnoProctoRectoscopes LED and not LED EUDAMEDTHD Light-Scope Procto HRA is composed by a THD Light-Scope LED anoscope and an adaptor that allow the coupling of the anoscope with a digital camera for inspection and investigation in high resolution of the anal canal. The Light-Scope LED anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. FDA UDI
- Model / Reference
- THD Not Sterile AnoProctoRectoscopes LED and not LED EUDAMED800191 EUDAMEDTHD Light-Scope Procto HRA FDA UDI
- Description
- THD Light-Scope Procto HRA is composed by a THD Light-Scope LED anoscope and an adaptor that allow the coupling of the anoscope with a digital camera for inspection and investigation in high resolution of the anal canal. The Light-Scope LED anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. FDA UDI
Identifiers
- Catalog Number
- 800191 FDA UDI
- Primary DI / UDI-DI
- 08033737712276 EUDAMEDFDA UDI
- Basic UDI-DI
- 803373771DIANS0003Y5 EUDAMED
- FDA Product Code
- GCP FDA UDIFER FDA UDI
- EMDN Code
- G02060301 ANOSCOPES EUDAMED
- GMDN Term
- Optical anoscope, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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 — 68 Millimeter FDA UDIOuter Diameter — 27 Millimeter FDA UDI
Thd Light-Scope Procto Hra by Thd S.p.a. — 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 | 803373771DIANS0003Y5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thd S.p.a.
- EUDAMED SRN
- IT-MF-000029427
Sources (2)
- EUDAMED 83532894-4008-4ba2-8aaf-8a5764a3c36f 61 fields · synced Aug 1, 2026
- FDA UDI 940dfb8a-494a-40b5-8aba-ccf47ea8568d 36 fields · synced May 30, 2026