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Sterile Adhesive Dressing
EUDAMEDClass I (EU MDR)
Ref 1200213Model A-Nonwoven, B-PU, C-Pad
Identity
- Device Name
- Sterile Adhesive Dressing EUDAMED
- Model / Reference
- A-Nonwoven, B-PU, C-Pad EUDAMED1200213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717484791523 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
- Netherlands 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 Dressing 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 |
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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 b1a863ff-15a0-4378-9648-a2e5a993c95f 61 fields · synced Oct 8, 2026