# Single-use Choledochoscope

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/single-use-choledochoscope-pch24-3>
- Manufacturer: [Hunan Endoso Life Technology Co., Ltd](https://devicerts.com/manufacturers/fda-fei-3030504644) (China)
- Device class: Class IIa (EU MDR)
- EMDN: Z12020507 VIDEO CHOLEDOCOSCOPES

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · 6124105CE01 · issued 2026-10-02 · expires 2029-11-01 · status: Active
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 697520277YS015LC · UDI-DI 06975202773349 · registered 2025-11-25 · status: Active

## EU certificates

- 6124105CE01 · Quality management system · MDR · notified body DEKRA Certification B.V. · issued 2026-04-20 · expires 2029-11-01 · status: amended (no longer listed by EUDAMED)
- 6124105CE01 · Quality management system · MDR · notified body DEKRA Certification B.V. · issued 2026-10-02 · expires 2029-11-01 · status: supplemented

## Recalls

No recall on record.

## Identity

- Device name: Single-use Choledochoscope [EUDAMED]
- Model / reference: PCH12-1 [EUDAMED]; PCH12-2 [EUDAMED]; PCH12-3 [EUDAMED]; PCH22-1 [EUDAMED]; PCH22-2 [EUDAMED]; PCH22-3 [EUDAMED]; PCH22-4 [EUDAMED]; PCH22-5 [EUDAMED]; PCH22-6 [EUDAMED]; PCH24-1 [EUDAMED]; PCH24-2 [EUDAMED]; PCH24-3 [EUDAMED]; PCH24-4 [EUDAMED]; PCH24-5 [EUDAMED]; PCH24-6 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 06975202773349 [EUDAMED]
- Basic UDI-DI: 697520277YS015LC [EUDAMED]
- Direct marketing DI: 06975202773349 [EUDAMED]
- EMDN code: Z12020507 [EUDAMED]

## Classification

- Device class: Class IIa [EUDAMED]
- System or procedure pack: Procedure pack which is a device in itself [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]

## Properties

- Supplied sterile: Yes [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Implantable: No [EUDAMED]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]

## Source and citation

- Cite as: Single-use Choledochoscope, Hunan Endoso Life Technology Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/single-use-choledochoscope-pch24-3 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/single-use-choledochoscope-pch24-3.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/single-use-choledochoscope-pch24-3
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.