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Bipolar Coagulation and Cutting Forceps
EUDAMEDClass IIb (EU MDR)
Ref BFI-5330K-EModel BFI Series
Identity
- Trade Name
- Bipolar Coagulation and Cutting Forceps EUDAMED
- Device Name
- Bipolar Coagulation and Cutting Forceps EUDAMED
- Model / Reference
- BFI Series EUDAMEDBFI-5330K-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123022677 EUDAMED
- Basic UDI-DI
- 471412302BFI-01MW EUDAMED
- EMDN Code
- K0201010602 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bipolar Coagulation and Cutting Forceps by Lagis Enterprise Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471412302BFI-01MW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lagis Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000007081
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 22013461-eb0e-4e9f-b5b1-48794f96593f 61 fields · synced Jun 18, 2026