← Back to catalogue
Wound Dressings
EUDAMEDClass I (EU MDR)
Ref 8911339Model A-Nonwoven, B-PU, C-PadRef 8911347
Identity
- Trade Name
- Wound Dressings EUDAMED
- Device Name
- Sterile Adhesive Dressing EUDAMED
- Model / Reference
- A-Nonwoven, B-PU, C-Pad EUDAMED8911339 EUDAMED8911347 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941762600224 EUDAMED16941762600231 EUDAMED
- Basic UDI-DI
- 69417626010UW EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Wound Dressings 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 | 69417626010UW | 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 (2)
- EUDAMED 928105db-57d5-4192-9a7b-7e2fb20f9d20 61 fields · synced Oct 6, 2026
- EUDAMED 32cb45cb-211a-4fd5-a5bc-99207e0503f0 61 fields · synced May 17, 2026