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Trocar kit
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref UNTR-AII5Ref UNTR-A1515GRef UNTB-RC0510-K2Ref UNTR-A1215GRef UNTR-A0507Ref UNTR-A0507GRef UNTR-II1210Ref UNTB-RC0507-K2Ref UNTR-AII1Ref UNTR-B0507Ref UNTR-CII5Ref UNTB-RC1110-K2Ref UNTR-A1510GRef UNTB-R1210Ref UNTB-RC1210-K2Ref UNTR-AII3Ref UNTR-A1510Ref UNTR-A1215Ref UNTR-A1110GRef UNTR-BII1Ref BTRDSB1510Ref UNTR-I0507510(k) K141594Ref UNTB-RD1210Ref UNTR-II0510Model UNTR-II1110Ref UNTR-C1110Ref UNTR-B0510Ref HTRRSB1010Ref UNTB-RC1210
Identity
- Trade Name
- Trocar kit EUDAMEDVisible Trocar FDA UDIVisible Balloon Trocar FDA UDIBladeless Trocar FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- Auto-locking Trocar Set EUDAMEDBarb Thread Cannula EUDAMEDVisible Balloon Trocar Set EUDAMEDAuto-locking Trocar EUDAMEDBladeless Trocar EUDAMEDVisible Trocar Set EUDAMEDBalloon Cannula EUDAMEDBladeless Trocar Set EUDAMEDHasson Balloon Trocar EUDAMEDVisible Trocar EUDAMEDHasson Trocar EUDAMEDVisible Balloon Trocar EUDAMED
- Model / Reference
- UNTR-AII5 EUDAMEDUNTR-A1515G EUDAMEDUNTB-RC0510-K2 EUDAMEDUNTR-A1215G EUDAMEDUNTR-A0507 EUDAMEDUNTR-A0507G EUDAMEDUNTR-II1210 EUDAMEDUNTB-RC0507-K2 EUDAMEDUNTR-AII1 EUDAMEDUNTR-B0507 EUDAMEDUNTR-CII5 EUDAMEDUNTB-RC1110-K2 EUDAMEDUNTR-A1510G EUDAMEDUNTB-R1210 EUDAMEDUNTB-RC1210-K2 EUDAMEDUNTR-AII3 EUDAMEDUNTR-A1510 EUDAMEDUNTR-A1215 EUDAMEDUNTR-A1110G EUDAMEDUNTR-BII1 EUDAMEDBTRDSB1510 EUDAMEDUNTR-I0507 EUDAMEDUNTR-C1110 EUDAMEDFDA UDIUNTB-RC1210 EUDAMEDFDA UDIUNTR-B0510 EUDAMEDFDA UDIUNTB-RD1210 EUDAMEDUNTR-II1110 EUDAMEDUNTR-II0510 EUDAMEDHTRRSB1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955797760160 EUDAMED06955797760436 EUDAMED06955797766292 EUDAMED06955797760412 EUDAMED06955797760016 EUDAMED06955797760337 EUDAMED06955797764113 EUDAMED06955797766285 EUDAMED06955797760122 EUDAMED06955797761013 EUDAMED06955797762164 EUDAMED06955797766308 EUDAMED06955797760429 EUDAMED06955797766186 EUDAMED06955797766315 EUDAMED06955797760146 EUDAMED06955797760108 EUDAMED06955797760092 EUDAMED06955797760382 EUDAMED06955797761129 EUDAMED06955797713197 EUDAMED06955797763017 EUDAMED06955797762065 EUDAMEDFDA UDI06955797766124 EUDAMEDFDA UDI06955797761020 EUDAMEDFDA UDI06955797766148 EUDAMED06955797764052 EUDAMED06955797715030 EUDAMED
- Basic UDI-DI
- B-06955797760160 EUDAMEDB-06955797760436 EUDAMEDB-06955797766292 EUDAMEDB-06955797760412 EUDAMEDB-06955797760016 EUDAMEDB-06955797760337 EUDAMEDB-06955797764113 EUDAMEDB-06955797766285 EUDAMEDB-06955797760122 EUDAMEDB-06955797761013 EUDAMEDB-06955797762164 EUDAMEDB-06955797766308 EUDAMEDB-06955797760429 EUDAMEDB-06955797766186 EUDAMEDB-06955797766315 EUDAMEDB-06955797760146 EUDAMEDB-06955797760108 EUDAMEDB-06955797760092 EUDAMEDB-06955797760382 EUDAMEDB-06955797761129 EUDAMEDB-06955797713197 EUDAMEDB-06955797763017 EUDAMEDB-06955797766148 EUDAMEDB-06955797764052 EUDAMEDB-06955797762065 EUDAMEDB-06955797761020 EUDAMEDB-06955797715030 EUDAMEDB-06955797766124 EUDAMED
- 510(k) Number
- FDA Product Code
- GCJ FDA 510(k)FDA UDI
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMEDK01010180 TROCAR, SINGLE-USE - ACCESSORIES EUDAMEDK01010103 OPTICAL TROCAR, SINGLE-USE EUDAMEDK01010102 HASSON TROCAR, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)FDA UDI
- Market of Registration
- Ireland EUDAMEDSpain EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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 — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141594 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06955797760160 | Class IIa | Active |
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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 (32)
- EUDAMED 9858bdce-dae0-4fae-82bb-3daff0e4afc8 61 fields · synced Aug 4, 2026
- EUDAMED c64304d8-1d23-47fa-9630-fb2208488202 61 fields · synced May 16, 2026
- EUDAMED 428588af-d736-41f6-826b-f8b0dab23362 61 fields · synced May 16, 2026
- EUDAMED b9dbd348-423e-4b13-8813-84ecc8e4f6f1 61 fields · synced May 16, 2026
- EUDAMED f3315fe7-bcf7-41b3-9483-da945717dc00 61 fields · synced May 16, 2026
- EUDAMED d1ee58c1-5e81-47a8-be8f-12f1f6c1d74d 61 fields · synced May 17, 2026
- EUDAMED 3829a269-ba06-482c-afda-de3b174d7826 61 fields · synced May 17, 2026
- EUDAMED f2cdafbb-2e3b-4008-aed8-19abc5e9c884 61 fields · synced May 17, 2026
- EUDAMED 9d03ae38-1569-49d5-80fe-e76477ceb5ad 61 fields · synced May 17, 2026
- EUDAMED 95082ba7-9d90-40d0-83e8-3b30178cc8c8 61 fields · synced May 17, 2026
- EUDAMED c35f4037-4578-4ee2-9083-2c9fda8b417c 61 fields · synced May 17, 2026
- EUDAMED d441013e-9a47-438e-bb65-0d50cec1ef45 61 fields · synced May 17, 2026
- EUDAMED b0f1b906-0f15-457b-8ba7-576bcabb90fb 61 fields · synced May 17, 2026
- EUDAMED 1b0081d8-faf2-4c5d-802b-801aa0533128 61 fields · synced May 17, 2026
- EUDAMED c19c513b-b05a-4291-980a-10b04d8172c7 61 fields · synced May 17, 2026
- EUDAMED d34d0638-a3ce-40ed-b9f2-9c43ba56525d 61 fields · synced May 17, 2026
- EUDAMED 8dfedfe3-93ea-43ed-a7f6-48da0640bb2d 61 fields · synced May 17, 2026
- EUDAMED eea9cb7e-4dfe-40c7-a3c2-075542d7f79a 61 fields · synced May 18, 2026
- EUDAMED a8b4053e-b4f6-4a85-ba47-f41c79f6969a 61 fields · synced May 18, 2026
- EUDAMED bd5dd968-6df9-42d1-b288-97bff78666fa 61 fields · synced May 18, 2026
- EUDAMED d0454542-9ae6-408d-8776-ec7dafecb8de 61 fields · synced May 18, 2026
- EUDAMED 6de40e00-7873-4aae-8374-30703d9647c3 61 fields · synced May 18, 2026
- FDA 510(k) K141594 24 fields · synced May 18, 2026
- FDA UDI 344d3492-0cc8-4aaa-bf49-a2393e66eb5a 33 fields · synced May 27, 2026
- FDA UDI a2ac4eba-35c7-4024-aa58-7fb1ced11d33 33 fields · synced May 30, 2026
- FDA UDI 0ea87cfe-3388-4678-ac54-c8350bf50c5e 33 fields · synced May 30, 2026
- EUDAMED c784fdd9-0c16-47d7-aee8-717dd5ca35cb 61 fields · synced Jul 8, 2026
- EUDAMED 0f675297-b69a-4d02-92a1-4ce143cb4f6d 61 fields · synced Jul 9, 2026
- EUDAMED d254ece5-bd6e-4cba-b770-0621a5d23746 61 fields · synced Jul 12, 2026
- EUDAMED 6b4a0282-83dc-4070-8c12-c18da91257ce 61 fields · synced Jul 13, 2026
- EUDAMED 28455560-e7d1-4863-a623-7a03e1275cd1 61 fields · synced Jul 15, 2026
- EUDAMED b4a76789-2b82-4d81-9df9-a439c7e1bcc8 61 fields · synced Jul 24, 2026