Identity
- Model / Reference
- Hydrocolloid Dressing EUDAMED5118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970944383207 EUDAMED
- Basic UDI-DI
- 697094438HYDDREVJ EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
5118 by Jiangsu Ostup Medical Products Co., Ltd. — Class IIa — 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 | 697094438HYDDREVJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Ostup Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000040133
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 2f4cc96d-d8f0-4710-8b96-88ec21b7d6a3 61 fields · synced Jul 9, 2026