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THD Light-Scope Procto HRA Kit Laser
EUDAMEDClass I (EU MDR)
Ref 800298Model THD Light-Scope Procto HRA Kit Laser
by Thd S.p.a.
Identity
- Trade Name
- THD Light-Scope Procto HRA Kit Laser EUDAMED
- Device Name
- THD Light-Scope Procto HRA Kit Laser EUDAMED
- Model / Reference
- THD Light-Scope Procto HRA Kit Laser EUDAMED800298 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051887042616 EUDAMED
- Basic UDI-DI
- 803373771DIANSSYS0002UN EUDAMED
- EMDN Code
- Z12020603 PROCTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- THD Light Scope Procto HRA is a DISPOSABLE device that is used for High Resolution Anoscopy examinations, therefore for the inspection of the anal canal and/or rectal ampulla, not under direct vision, but through magnified vision through a highspeed acquisition system high resolution. Furthermore, by using the THD HR liquid dispenser and THD HRA laser handpiece accessories, it is possible to make a better diagnosis and treat any pathologies using the CO2 laser. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Category: Sphincteroscope
THD Light-Scope Procto HRA Kit Laser by Thd S.p.a. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Sphincteroscope.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803373771DIANSSYS0002UN | Class I | Active |
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Manufacturer
- Manufacturer
- Thd S.p.a.
- EUDAMED SRN
- IT-PR-000029428
Sources (1)
- EUDAMED 25ad068f-dee4-4b70-b981-dd739260b0ba 61 fields · synced Jun 18, 2026