Identity
- Trade Name
- SW-BMC Kit EUDAMED
- Device Name
- SW-BMC Kit EUDAMED
- Model / Reference
- SW-BMC Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272563334 EUDAMED
- Basic UDI-DI
- B-08809272563334 EUDAMED
- EMDN Code
- A01020299 NEEDLES AND KITS - BONE MARROW BIOPSY - 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-BMC Kit 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-08809272563334 | 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 447a4afc-04e4-4b4b-8d3e-342ea15de30e 61 fields · synced Jul 14, 2026