Identity
- Trade Name
- Laport EUDAMEDFDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- N21-0510 EUDAMED
- Model / Reference
- N21-0510 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- N21-0510 FDA UDI
- Primary DI / UDI-DI
- 08806182210372 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806182210372 EUDAMED
- 510(k) Number
- K171741 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Laport by Sejong Medical Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806182210372 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SEJONG MEDICAL Co., Ltd.
- EUDAMED SRN
- KR-MF-000020090
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED daac9cfc-95f0-4d99-846c-39959a02c6c6 61 fields · synced May 30, 2026
- FDA UDI b204f879-1875-427d-b62f-7f59254a5dae 34 fields · synced May 30, 2026