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Thd N-Ano Digital Maxi (be)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 800316Model THD N-ANO DIGITAL (TR)
by Thd S.p.a.
Identity
- Trade Name
- THD N-ANO DIGITAL MAXI (BE) EUDAMEDTHD N-ano anoscope FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- THD N-ANO DIGITAL (TR) EUDAMEDTHD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integrates in the handle the seat for a dedicated slide for association of anoscope with THD DIGITAL MINICAM which allowing HD resolution shooting of the anoscopy examination. THD N-ANO DIGITAL anoscope is supplied with a convenient introducer, a camera slide and a camera protection bag. FDA UDI
- Model / Reference
- THD N-ANO DIGITAL (TR) EUDAMED800316 EUDAMEDTHD N-ANO DIGITAL MAXI (BE) FDA UDI
- Description
- THD N-ano Digital is a disposable medical device shaped so that it can be easily inserted into the anal cavity and which integrates in the handle the seat for a dedicated slide for association of anoscope with THD DIGITAL MINICAM which allowing HD resolution shooting of the anoscopy examination. THD N-ANO DIGITAL anoscope is supplied with a convenient introducer, a camera slide and a camera protection bag. FDA UDI
Identifiers
- Catalog Number
- 800316 FDA UDI
- Primary DI / UDI-DI
- 08051887044771 EUDAMEDFDA UDI
- Basic UDI-DI
- 803373771DIANS0005Y9 EUDAMED
- 510(k) Number
- K133687 FDA UDI
- 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
- Outer Diameter — 25.8 Millimeter FDA UDILength — 91 Millimeter FDA UDI
Thd N-Ano Digital Maxi (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 | 803373771DIANS0005Y9 | 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 55166725-59b6-4d8b-8b83-678148ba6824 61 fields · synced Jun 19, 2026
- FDA UDI a320778b-ef4e-469c-a2fd-bc268a6222fd 37 fields · synced May 30, 2026