Identity
- Trade Name
- Relistat+Nasal Wool Calcium Alginate Wound Dressing EUDAMED
- Device Name
- Calcium alginate wound dressings EUDAMED
- Model / Reference
- 402.021001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958868780043 EUDAMED
- Basic UDI-DI
- B-06958868780043 EUDAMED
- EMDN Code
- M04040201 ALGINATE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany 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
Calcium alginate wound dressings by Roosin Medical Co., Ltd. — Class IIb — 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-06958868780043 | Class IIb | 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 d7a75eb7-c70c-4dab-951f-2988fb704237 61 fields · synced Jul 29, 2026
- EUDAMED 87b679b8-63d8-4604-a9fd-dccfacaaa5c0 61 fields · synced Jul 29, 2026