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Sterile adhesive wound dressing
EUDAMEDClass I (EU MDR)
Ref 1130203012Model A-Nonwoven, B-PU, C-Pad
Identity
- Trade Name
- Sterile adhesive wound dressing EUDAMED
- Device Name
- Sterile Adhesive Dressing EUDAMED
- Model / Reference
- A-Nonwoven, B-PU, C-Pad EUDAMED1130203012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941762602976 EUDAMED
- Basic UDI-DI
- 69417626010UW EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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 wound dressing by Changzhou Hualian Health Dressing Co., Ltd — Class I — CE/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 |
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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 (1)
- EUDAMED f6e5786e-6ba7-4bab-ab8b-dde596350e7a 61 fields · synced Oct 6, 2026