Identity
- Device Name
- Absorbent Pads EUDAMED
- Model / Reference
- 409.008001 EUDAMED409.008002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868784000 EUDAMED16958868784017 EUDAMED
- Basic UDI-DI
- B-16958868784000 EUDAMEDB-16958868784017 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Absorbent Pads by Roosin Medical Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16958868784000 | Class I | Active |
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Manufacturer
- Manufacturer
- Roosin Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021163
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 1e44274b-bef9-42d2-9df0-f2c4331ced2f 61 fields · synced Jul 21, 2026
- EUDAMED 3c7e84e4-bdaa-4aba-989e-d4b6ec7439cb 61 fields · synced May 18, 2026