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Pansement adhésif stérile avec compresse centrale
EUDAMEDClass I (EU MDR)
Ref 061310Model A-Nonwoven, B-PU, C-PadRef 061304Ref 061301Ref 061312
Identity
- Trade Name
- Pansement adhésif stérile avec compresse centrale EUDAMED
- Device Name
- Sterile Adhesive Dressing EUDAMED
- Model / Reference
- A-Nonwoven, B-PU, C-Pad EUDAMED061310 EUDAMED061304 EUDAMED061301 EUDAMED061312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941762600392 EUDAMED16941762600378 EUDAMED16941762600361 EUDAMED16941762600385 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
- France 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
Pansement adhésif stérile avec compresse centrale by Changzhou Hualian Health Dressing Co., Ltd — Class I — MDR — listed in EUDAMED
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 (4)
- EUDAMED 9b5de4a1-21cf-43fb-8ddc-c563d0169d79 61 fields · synced Oct 6, 2026
- EUDAMED a07f87d6-83d5-40d7-a177-7b0bbf43caa0 61 fields · synced May 17, 2026
- EUDAMED 67d7b4b9-6611-4f49-8e7f-3e1c53578cde 61 fields · synced May 18, 2026
- EUDAMED b046f240-1745-4783-88c2-38d72d7aee30 61 fields · synced May 19, 2026