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Navisel
EUDAMEDClass IIb (EU MDR)
Ref SWVGDC-1250ARef SWVGDC-650ARef SWVGDC-900A
Identity
- Trade Name
- Navisel EUDAMED
- Device Name
- Navisel EUDAMED
- Model / Reference
- SWVGDC-1250A EUDAMEDSWVGDC-650A EUDAMEDSWVGDC-900A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272564041 EUDAMED08809272564065 EUDAMED08809272564058 EUDAMED
- Basic UDI-DI
- B-08809272564041 EUDAMEDB-08809272564065 EUDAMEDB-08809272564058 EUDAMED
- EMDN Code
- C0699 CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical bulldog clamp, single-use
Navisel by Seawon Meditech Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical bulldog clamp, 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-08809272564041 | 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 (3)
- EUDAMED 20ad7a2c-2fd6-431d-bed2-5e32b9d3b36b 61 fields · synced Jul 23, 2026
- EUDAMED 38305359-83a8-4368-b2ad-fe59b9917213 61 fields · synced May 18, 2026
- EUDAMED 4f9053b9-ae6e-41c3-ad9e-d2e62923333d 61 fields · synced May 19, 2026