Identity
- Trade Name
- 5mm Seal EUDAMEDYelloPort Elite FDA UDI
- Generic Name
- Laparoscopic access cannula seal, single-use FDA UDI
- Device Name
- 5mm Seal EUDAMEDFDA UDISingle use Seal / Valve EUDAMED
- Model / Reference
- EA05XL EUDAMEDFDA UDI
- Description
- 5mm seal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986013077 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051986013077 EUDAMED5051986SISUS59 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 seal, single-use 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
5mm Seal by Surgical Innovations Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05051986013077 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05051986013077 | 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 719c9363-adfa-4b97-b286-a48e92314927 61 fields · synced Jun 18, 2026
- EUDAMED fe7dfebb-c7ad-4be7-9dba-427c61aee3af 61 fields · synced May 19, 2026
- FDA UDI ae4642f6-211e-4629-927c-18845ab5acdf 34 fields · synced May 30, 2026