Identity
- Trade Name
- Access Kit EUDAMED
- Device Name
- Laparoscopic Kit-LB Kit EUDAMED
- Model / Reference
- LB kit EUDAMEDLB-A01S EUDAMEDLB-A01XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714123023520 EUDAMED04714123025395 EUDAMED
- Basic UDI-DI
- 471412302LB-01RG EUDAMED
- EMDN Code
- K01020120 MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- A kit is one or more products that can be used together or are compatible with device as the intended use described and are listed as a kit. LB kit is consisted of Wound Retractor and Cap for Wound Retractor and part of model is contained Trocar. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Access Kit by Lagis Enterprise Co., Ltd. — Class IIa — 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 | 471412302LB-01RG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lagis Enterprise Co., Ltd.
- EUDAMED SRN
- TW-PR-000026825
Sources (2)
- EUDAMED 3dc9ed54-9a07-429e-992a-2a3d81dda31c 61 fields · synced Jul 18, 2026
- EUDAMED 29fe6941-77a5-40bf-8163-fedd61ba2baf 61 fields · synced May 17, 2026