Identity
- Device Name
- Paraffin Gauze Dressing EUDAMED
- Model / Reference
- 505.010005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868783126 EUDAMED
- Basic UDI-DI
- B-16958868783126 EUDAMED
- EMDN Code
- M02030201 GAUZE IMPREGNATED WITHOUT ANTISEPTIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Paraffin Gauze Dressing by Roosin Medical Co., Ltd. — Class IIa — 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-16958868783126 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Roosin Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000021163
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED cab4d5f2-775f-42e3-9f46-828e5aed7d81 61 fields · synced Jun 18, 2026