← Back to catalogue
Plaster
EUDAMEDClass I (EU MDR)
Ref WZWZ002Model /Ref 1161163Ref WZWZ003Ref PPL20-212Model A-Nonwoven, B-Cotton, C-Elastic fabric
Identity
- Trade Name
- Plaster EUDAMED
- Device Name
- Zinc Oxide Adhesive Plaster EUDAMEDSelf-adhesive Bandage EUDAMED
- Model / Reference
- / EUDAMEDWZWZ002 EUDAMED1161163 EUDAMEDWZWZ003 EUDAMEDA-Nonwoven, B-Cotton, C-Elastic fabric EUDAMEDPPL20-212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941762602754 EUDAMED16941762602747 EUDAMED16941762602808 EUDAMED16941762603003 EUDAMED
- Basic UDI-DI
- 69417626001UV EUDAMED69417626004V3 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMEDM04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDNorway EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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
Plaster by Changzhou Hualian Health Dressing 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 | 69417626001UV | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Changzhou Hualian Health Dressing Co., Ltd.
- EUDAMED SRN
- CN-MF-000021134
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED c55e0fb1-cec7-412e-8ff3-ca79b10d2221 61 fields · synced Oct 6, 2026
- EUDAMED 936b01e0-87e1-473a-bf1b-4dd5a6254baa 61 fields · synced May 18, 2026
- EUDAMED 26dbc2a0-c2c0-45ec-b785-7d0f1299b3de 61 fields · synced May 18, 2026
- EUDAMED 19828cee-1e90-4f92-956a-0834975558d6 61 fields · synced Jul 12, 2026