Identity
- Trade Name
- Blisterplasters EUDAMED
- Device Name
- Blister Plaster/Bunion plaster EUDAMED
- Model / Reference
- 543411 EUDAMED543404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717928543411 EUDAMED08717928543404 EUDAMED
- Basic UDI-DI
- 69380562BP123KG EUDAMED
- Unit of Use DI
- 88717928543417 EUDAMED88717928543400 EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Blisterplasters 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 | 69380562BP123KG | 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 474390d2-0eb3-43a0-a8e5-2264d0a79251 61 fields · synced Oct 6, 2026
- EUDAMED 7954a2e3-9112-4986-86c0-f47bbdcaf851 61 fields · synced May 17, 2026