Identity
- Trade Name
- Sterile Eye Dressing EUDAMED
- Device Name
- Sterile Eye Pad EUDAMED
- Model / Reference
- All Sizes EUDAMEDD7889C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864859715 EUDAMED
- Basic UDI-DI
- 697386485EyePadMX EUDAMED
- EMDN Code
- M040301 EYE PADS, COTTON OR NON-WOVEN MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Dressing by Suzhou Sunmed 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 | 697386485EyePadMX | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a794ff61-ca9d-489c-8a0e-7d64cbd3f45c 61 fields · synced Jun 18, 2026