Digital Camera Module Kit
by Shanghai Mediworks Precision Instruments Co., Ltd. 2 variants
Ref DS650Model DM390
Digital Camera Module Kit (DS650) is an ophthalmic examination slit lamp (EU MDR Class I; FDA Class I; FDA product code OUG, Medical Device Data System) made by Shanghai Mediworks Precision Instruments Co., Ltd., registered in EUDAMED on 16 Jul 2025 (Basic UDI-DI 69450875DigitalModule5T) and listed in FDA GUDID since 9 Oct 2026 (UDI-DI 06945087500439), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06945087500439 | Date9 Oct 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number69450875DigitalModule5T 06945087500439 | Date16 Jul 2025 | StatusActive |
Official records
- EUDAMED public site 69450875DigitalModule5T
- AccessGUDID record 06945087500439
Across registries
- EUDAMED Basic UDI-DI 69450875DigitalModule5T registered 16 Jul 2025 Active
- FDA GUDID UDI-DI 06945087500439 listed 9 Oct 2026 Listed
Timeline
- Registered EUDAMED 69450875DigitalModule5T
- Listed FDA GUDID 06945087500439
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Digital Camera Module Kit EUDAMEDEssilor GUDID
- Generic name
- Ophthalmic examination slit lamp
- Model / reference
- DM390, DS650
- Primary DI / UDI-DI
- 06945087500439
- Basic UDI-DI
- 69450875DigitalModule5T
- Direct marketing DI
- 06945087500439
- FDA product code
- OUG
- EMDN code
- Z12129099 Various ophtalmology instruments - other
- GMDN term
- Ophthalmic examination slit lamp
- Device class
- Class I
- Regulation number
- 880.6310
- EU registration type
- Standard device
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- CN-MF-000004251
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Similar devices in this category
Other devices filed under VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER.
- Safety filter for Leica Microscopes, Passive 8005.F4 by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Precision Mount for B&L 10039400 by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
- SDI 4m mechanically 54302 by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
- Auto Lensmeter B4ARAA-17-00001 by Huvitz Co., Ltd.
- Safety filter for Zeis/Moeller-Wedel Microscopes, Manual 8005.F1 by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
- Auto Lensmeter B2VSSM-20-00001 by Huvitz Co., Ltd.
- Pupilometer HX4/1 by CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD
- Conjunctival Probe CP01 by BLINK MEDICAL LIMITED
- SOLOS 42-0001417 by VISIA IMAGING SRL
Other devices from Shanghai Mediworks Precision Instruments Co., Ltd.
See all devices from Shanghai Mediworks Precision Instruments Co., Ltd. →