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Irrigation Solutions for Eye and Wound Washes
EUDAMEDClass IIa (EU MDR)
Ref 510.309003
Identity
- Device Name
- Irrigation Solutions for Eye and Wound Washes EUDAMED
- Model / Reference
- 510.309003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16958868787032 EUDAMED
- Basic UDI-DI
- B-16958868787032 EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS 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
Irrigation Solutions for Eye and Wound Washes 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-16958868787032 | 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 7938fb34-efa2-47ef-87fa-8184b31a4448 61 fields · synced Jun 19, 2026