Identity
- Trade Name
- ABMC Kit EUDAMED
- Device Name
- ABMC Kit EUDAMED
- Model / Reference
- ABMC Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272563716 EUDAMED
- Basic UDI-DI
- B-08809272563716 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
ABMC 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-08809272563716 | 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 75278d8a-c47c-4d59-b7c1-595415e8d034 61 fields · synced Jun 19, 2026