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Loupes
EUDAMEDClass I (EU MDR)
Ref FDJ001Model JY-EW1,JY-EW2,JY-DS1,JY-DS2,JY-ES1,JY-ES2,JY-ES3,JY-ES4,JY-AIO1,JY-AIO2,JY-AIO3,JY-ECP,JY-EKJ,JY-FDG,JY-MGB,JY-MGC,JY-MGL,JY-XRS,JY-MFO,JY-MFB,JY-PSL;
Identity
- Device Name
- LOUPES EUDAMED
- Model / Reference
- JY-EW1,JY-EW2,JY-DS1,JY-DS2,JY-ES1,JY-ES2,JY-ES3,JY-ES4,JY-AIO1,JY-AIO2,JY-AIO3,JY-ECP,JY-EKJ,JY-FDG,JY-MGB,JY-MGC,JY-MGL,JY-XRS,JY-MFO,JY-MFB,JY-PSL; EUDAMEDFDJ001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977849490030 EUDAMED
- Basic UDI-DI
- 697784949FDJ001TE EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Device sterilization/disinfection container, reusable
Loupes by Foshan Chengsu Precision Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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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 | 697784949FDJ001TE | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Chengsu Precision Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000044431
- Authorised Representative
- REP Europe GmbH DE-AR-000025090
Sources (1)
- EUDAMED 2bcf11e3-04a3-40b3-be4a-c02dfbcc169b 61 fields · synced Jun 18, 2026