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Endoscopic Instruments- Scissors
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref EI-330S-TModel EI Series510(k) K253134
Identity
- Trade Name
- Endoscopic Instruments- Scissors EUDAMED
- Device Name
- Endoscopic Instruments- Scissors EUDAMED
- Model / Reference
- EI Series EUDAMEDEI-330S-T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123024732 EUDAMED
- Basic UDI-DI
- 471412302EI-01QL EUDAMED
- EMDN Code
- K0201010402 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY SCISSORS, 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- Scissors 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 | K253134 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 471412302EI-01QL | 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 7ce71fac-d34a-4a4b-adc7-1a27b893b958 85 fields · synced Jun 18, 2026
- FDA 510(k) K253134 1 fields · synced Jun 4, 2026