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Visible Balloon Trocar UNTB-RC1210

by Unimicro Medical Systems (ShenZhen) Co., Ltd.

Ref UNTB-RC1210

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06955797766124 Basic UDI-DI 06955797766124UDI-DIDate27 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06955797766124 UDI-DI Date3 Sep 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Trocar kit EUDAMED
Visible Balloon Trocar GUDID
Generic Name
Laparoscopic access cannula, single-use
Model / Reference
UNTB-RC1210
Primary DI / UDI-DI
06955797766124
Basic UDI-DI
B-06955797766124
510(k) Number
FDA Product Code
GCJ
EMDN Code
K01010103 Optical trocar, single-use
GMDN Term
Laparoscopic access cannula, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K141594)

Show all (12)

Other devices from Unimicro Medical Systems (ShenZhen) Co., Ltd.

See all devices from Unimicro Medical Systems (ShenZhen) Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No