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12x105 Optical Bladeless Port System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ESU1210505
Identity
- Trade Name
- 12x105 Optical Bladeless Port System EUDAMEDYelloPort Elite FDA UDI
- Generic Name
- Laparoscopic access cannula, reusable FDA UDI
- Device Name
- Optical Bladeless Port System EUDAMED12x105 Optical Bladeless Port System EUDAMEDFDA UDI
- Model / Reference
- ESU1210505 EUDAMEDFDA UDI
- Description
- 12x105 Optical Bladeless Port System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986012247 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051986SISUP53 EUDAMEDB-05051986012247 EUDAMED
- 510(k) Number
- K210495 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, 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
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
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 Optical Bladeless Port System by Surgical Innovations Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 5051986SISUP53 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5051986SISUP53 | 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 (3)
- EUDAMED 2e3cdbc0-f57d-4250-b146-7fe852e08535 61 fields · synced Jul 30, 2026
- EUDAMED 8855e940-d901-41b9-836b-66a11875d194 61 fields · synced May 19, 2026
- FDA UDI dcb9b267-dd5f-464d-8027-90f31e1e8df1 34 fields · synced May 30, 2026