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Endoscopic Instruments-Dissector
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref DI-5770-45CModel DI Series
Identity
- Trade Name
- Endoscopic Instruments-Dissector EUDAMED
- Device Name
- Endoscopic Instruments-Dissector EUDAMED
- Model / Reference
- DI Series EUDAMEDDI-5770-45C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123022417 EUDAMED
- Basic UDI-DI
- 471412302DI-01Q9 EUDAMED
- EMDN Code
- K0201010202 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, 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
Endoscopic Instruments-Dissector by Lagis Enterprise Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090309 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 471412302DI-01Q9 | 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 (2)
- EUDAMED d2ea2ecc-b6bd-44a7-bc2e-78e6866e4a45 61 fields · synced Jul 15, 2026
- FDA 510(k) K090309 1 fields · synced May 18, 2026