Identity
- Trade Name
- 12x105 Bladeless Optical Trocar EUDAMEDYelloPort Elite FDA UDI
- Generic Name
- Laparoscopic access cannula, reusable FDA UDI
- Device Name
- 12x105 Bladeless Optical Trocar EUDAMEDFDA UDI
- Model / Reference
- EO1210505 EUDAMEDFDA UDI
- Description
- 12x105 Bladeless Optical Trocar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986012490 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051986012490 EUDAMED
- 510(k) Number
- K210495 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01010103 OPTICAL TROCAR, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic access cannula, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Ireland 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
12x105 Bladeless Optical Trocar by Surgical Innovations 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-05051986012490 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Surgical Innovations Ltd.
- EUDAMED SRN
- GB-MF-000012187
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED cf49e78f-ae80-4904-ad0e-7b409bc784b6 61 fields · synced Sep 17, 2026
- FDA UDI 1ad1dac7-bf1c-4211-8a08-29a9800c8cbd 34 fields · synced May 30, 2026