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Pleister strips
EUDAMEDClass I (EU MDR)
Ref 1200212Model A-Elastic fabric, B-PE, C-PU
Identity
- Trade Name
- Pleister strips EUDAMED
- Device Name
- Sterile Bandage EUDAMED
- Model / Reference
- A-Elastic fabric, B-PE, C-PU EUDAMED1200212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717484000458 EUDAMED
- Basic UDI-DI
- 69417626012V2 EUDAMED
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER 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
Pleister strips 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 a4d71d1d-d93d-457c-ae6b-7ed77c29dd9d 61 fields · synced Oct 6, 2026