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Thd N-Ano (be)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 800134Model THD Not Sterile AnoProctoRectoscopes LED and not LED
by Thd S.p.a.
Identity
- Trade Name
- THD N-ANO (BE) EUDAMEDTHD N-ano anoscope FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- THD Not Sterile AnoProctoRectoscopes LED and not LED EUDAMEDThe THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal. The THD N-ano 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. The THD N-ano anoscope is ready-to-use and does not need for other tools. FDA UDI
- Model / Reference
- THD Not Sterile AnoProctoRectoscopes LED and not LED EUDAMED800134 EUDAMEDTHD Anoscope N-ano Bevelled FDA UDI
- Description
- The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal. The THD N-ano 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. The THD N-ano anoscope is ready-to-use and does not need for other tools. FDA UDI
Identifiers
- Catalog Number
- 800134 FDA UDI
- Primary DI / UDI-DI
- 08033737710708 EUDAMEDFDA UDI
- Basic UDI-DI
- 803373771DIANS0002Y3 EUDAMED
- 510(k) Number
- K133687 FDA UDI
- FDA Product Code
- FER FDA UDIGCP 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
- Outer Diameter — 21.7 Millimeter FDA UDILength — 105 Millimeter FDA UDI
Thd N-Ano (be) 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 | 803373771DIANS0002Y3 | 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 12e33a3d-1c88-4da6-adb5-bf3677f21678 61 fields · synced Jul 21, 2026
- FDA UDI 4c4f8322-020d-48a0-9cb0-0fc87efaaa0a 37 fields · synced May 30, 2026