Identity
- Trade Name
- SW-PRP EUDAMED
- Device Name
- SW-PRP EUDAMED
- Model / Reference
- SW-PRP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272560937 EUDAMED
- Basic UDI-DI
- B-08809272560937 EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER 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
Sw-Prp by Seawon Meditech 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-08809272560937 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Seawon Meditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000007442
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED b0f182cb-bad4-4b75-85d6-8c5d564122e6 61 fields · synced Jul 11, 2026