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Sterile Adhesive Dressing
EUDAMEDClass I (EU MDR)
Ref SA4201Model Nonwoven typeRef SA4202
Identity
- Trade Name
- Sterile Adhesive Dressing EUDAMED
- Device Name
- wound dressings EUDAMED
- Model / Reference
- Nonwoven type EUDAMEDSA4201 EUDAMEDSA4202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938056233278 EUDAMED06938056233285 EUDAMED
- Basic UDI-DI
- 69380562FT003MD EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Adhesive Dressing by Zhejiang Hongyu Medical Commodity 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 | 69380562FT003MD | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Hongyu Medical Commodity Co., Ltd
- EUDAMED SRN
- CN-MF-000008204
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED e1606141-a48a-4ad2-9da6-08bd63d34dd5 61 fields · synced Oct 6, 2026
- EUDAMED a1ad870e-eb88-4ad1-b1c0-e56a6f5b22d0 61 fields · synced May 17, 2026