Identity
- Device Name
- Sterile eye patches EUDAMED
- Model / Reference
- 8.5*5.5CM EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958689900665 EUDAMED
- Basic UDI-DI
- 69586899SEP001000246 EUDAMED
- EMDN Code
- M040305 OPHTHALMIC DRESSINGS IN THE FORM OF EYE DROPS/GEL/CREAMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile eye patches by Pujiang Jianyu Sanitary Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69586899SEP001000246 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pujiang Jianyu Sanitary Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000043742
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a3c129b7-0e3d-4fe8-995d-f3ce3d4fc56e 61 fields · synced Oct 7, 2026