← Back to catalogue
Apósitos Clásicos
EUDAMEDClass I (EU MDR)
Ref GP-400533Model A-Elastic fabric, B-PE, C-PU
Identity
- Trade Name
- APÓSITOS CLÁSICOS EUDAMED
- Device Name
- Sterile Bandage EUDAMED
- Model / Reference
- A-Elastic fabric, B-PE, C-PU EUDAMEDGP-400533 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941762603027 EUDAMED
- Basic UDI-DI
- 69417626012V2 EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Apósitos Clásicos 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 |
Is this your device? Claim it to add documentation and request validation.
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 2a6ce35d-c0e3-4acf-9efd-24c9333faa95 61 fields · synced Oct 7, 2026