Identity
- Trade Name
- Telescope 30° EUDAMED
- Device Name
- Telescope EUDAMED
- Model / Reference
- T1313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014623327 EUDAMED
- Basic UDI-DI
- 69470146RJ00522510SY EUDAMED
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Rigid video hysteroscope
Telescope 30° by Hangzhou Hawk Optical Electronic Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid video hysteroscope.
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HTx Jednorazowy Histeroskop — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
- Hysteroscope — Innoview GmbH · Class IIa
- EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
- HYSTEROSCOPE — Henke-Sass, Wolf GmbH · Class IIa
- Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
- Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
- Histeroscópio Descartável HTx — Suzhou AcuVu Medical Technology Co., Ltd. · Class IIa
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 | 69470146RJ00522510SY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000028791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6ae7c5ef-d6dd-4479-9e80-bb221ebef207 61 fields · synced Jul 25, 2026