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Abro
EUDAMEDClass IIb (EU MDR)
Ref SWF31VP31FRef SWF31VP34FRef SWF31VP33FRef SWF31VP32FRef SWF31VP35FRef SWF23VP26FRef SWF23VP25F
Identity
- Trade Name
- ABRO EUDAMED
- Device Name
- ABRO & Turtle Gun EUDAMED
- Model / Reference
- SWF31VP31F EUDAMEDSWF31VP34F EUDAMEDSWF31VP33F EUDAMEDSWF31VP32F EUDAMEDSWF31VP35F EUDAMEDSWF23VP26F EUDAMEDSWF23VP25F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272560852 EUDAMED08809272562740 EUDAMED08809272563204 EUDAMED08809272560869 EUDAMED08809272563211 EUDAMED08809272563198 EUDAMED08809272563181 EUDAMED
- Basic UDI-DI
- B-08809272560852 EUDAMEDB-08809272562740 EUDAMEDB-08809272563204 EUDAMEDB-08809272560869 EUDAMEDB-08809272563211 EUDAMEDB-08809272563198 EUDAMEDB-08809272563181 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Abro by Seawon Meditech Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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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-08809272560852 | Class IIb | 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 (7)
- EUDAMED d9d7fd86-54d6-423a-b4ce-5aa70878d664 61 fields · synced Jul 26, 2026
- EUDAMED 6762127b-9dd4-4a1c-b269-a6c4c3a09e3f 61 fields · synced May 17, 2026
- EUDAMED 1a953d4d-6072-43fb-8e98-3670cb0710e8 61 fields · synced May 17, 2026
- EUDAMED f9e66544-83eb-439e-aa67-b0c24dba0f6e 61 fields · synced May 18, 2026
- EUDAMED b1f7cee0-2641-4e53-906f-dcb7209394eb 61 fields · synced May 19, 2026
- EUDAMED 4f8e5698-12da-4aef-bafb-63413f600144 61 fields · synced May 19, 2026
- EUDAMED 65561e28-424b-43bd-ac44-39c8642e2521 61 fields · synced May 19, 2026