Identity
- Trade Name
- Trocar kit EUDAMEDVisible Balloon Trocar FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- Visible Balloon Trocar EUDAMED
- Model / Reference
- UNTB-RC1110 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06955797766117 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06955797766117 EUDAMED
- 510(k) Number
- K141594 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01010103 OPTICAL TROCAR, 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
- 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Trocar kit by Unimicro Medical Systems (shenzhen) Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06955797766117 | Class IIa | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Unimicro Medical Systems (Shenzhen) Co., Ltd
- EUDAMED SRN
- CN-MF-000014590
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED c7d3c987-fd53-4f0f-aee4-c4a34169c82e 61 fields · synced Jun 8, 2026
- FDA UDI 5a06d809-db5b-470b-89a1-3099d8f5b5df 33 fields · synced May 29, 2026