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Adhesive Nonwoven Dressings
EUDAMEDClass I (EU MDR)
Ref 061205Model A-Elastic fabric, B-PE, C-PU
Identity
- Trade Name
- Adhesive Nonwoven Dressings EUDAMED
- Device Name
- Sterile Bandage EUDAMED
- Model / Reference
- A-Elastic fabric, B-PE, C-PU EUDAMED061205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941762600583 EUDAMED
- Basic UDI-DI
- 69417626012V2 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Adhesive Nonwoven 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 | 69417626012V2 | 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 604b2597-1c43-4dbf-8dce-406022cb57ec 61 fields · synced Oct 6, 2026