FDA.reportPublic FDA data

Micro-Tech (Nanjing) Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134404003013440400Micro-Tech (Nanjing) Co., Ltd.1N2027-01-01No. 199 Medicine Valley Avenue, Nanjing National Hi-Tech Industrial Development Zone Nanjing Jiangsu CN 210032

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
06932503516563Sphincterotome / short-wire compatible - Sphincterotome / short-wire compatible, lumen 3, TIP length 2mm, cutting wire 30mm, Outside diameter 2.5mm, Cone, half Insulation, preload 4.5m guidewire, Single Cutting wire877-552-4027info@micro-tech-usa.com
06932503540353Disposable Biopsy Forceps - General handle, Two Wire, 6.7 mm opening width, MIM Alligator, With needle, Single outer sheath, FEP coating, 2.3*2300 mm877-552-4027info@micro-tech-usa.com
06932503540360Disposable Biopsy Forceps - General handle, Two Wire, 6.7 mm opening width, MIM Alligator, Without needle, Single outer sheath, FEP coating, 2.3*2300 mm877-552-4027info@micro-tech-usa.com
06932503540377Disposable Biopsy Forceps - General handle, Two Wire, 6.7 mm opening width, MIM Oval, With needle, Single outer sheath, FEP coating, 2.3*2300 mm877-552-4027info@micro-tech-usa.com
06932503540384Disposable Biopsy Forceps - General handle, Two Wire, 6.7 mm opening width, MIM Oval, Without needle, Single outer sheath, FEP coating, 2.3*2300 mm877-552-4027info@micro-tech-usa.com
06932503563857Additional Working Channel - Compatible OD of Endoscope:φ9.8mm-φ10.5mm, Working Length: 1175mm,Compatible working length of Endoscope:1030mm/1050mm/1100mm.877-552-4027info@micro-tech-usa.com
06932503563864Additional Working Channel - Compatible OD of Endoscope:φ10.9mm-φ11.8mm, Working Length: 1475mm,Compatible working length of Endoscope:1300mm/1330mm.877-552-4027info@micro-tech-usa.com
06932503563871Additional Working Channel - Compatible OD of Endoscope:φ12.6mm-φ13.2mm, Working Length: 1780mm,Compatible working length of Endoscope:1680mm/1690mm/1700mm.877-552-4027info@micro-tech-usa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1961981345251025K260262Injection NeedleFBK2026-05-29
1961981669349932K254153Single-use Video Scope; PB Digital ControllerFBN2026-04-03
1961981022844741K253832Dilation Balloon CatheterFGE2026-04-24
1961981994940255K253139Disposable Distal CapFBN2026-03-19
1961981941411592K252492Visualized Access and Delivery Catheter; PB Digital ControllerSHU2026-04-24
1961981783940161K251692Advanced Tissue Resection DeviceFDI2026-02-21
1961981348983775K250229Dual Action Tissue Closure DevicePKL2025-09-08
1961982015010201K243471Extraction BasketLQR2024-12-16
1961981540643072K243388Disposable Distal CapFDS2025-06-27
1961981316342725K233772Disposable Dual Action Tissue Closure DevicePKL2024-03-19
1961981486069441K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatibleFGE2023-09-06
1961981407359831K222354Elastic Traction SystemQSW2022-10-03
1961981674486573K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBN2023-02-16
1961981875671735K220424Through the Scope Tracheal Stent SystemJCT2022-07-08
1961981548910754K220247Guidewire Locking DeviceODC2022-03-29
1961981844709603K220157Disposable Hemostatic Closure Clip DevicePKL2022-06-13
1961981315499317K213782Single-Use Video Bronchoscopes, Digital ControllerEOQ2022-07-08
1961981679371193K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration NeedleKTI2022-07-20
1961981706650345K212852Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration NeedleODG2021-12-06
1961981528637809K212748Disposable Dual Action Tissue ClipPKL2022-01-20
1961981160110427K212403Tracheal Stent System (Y-Shaped)JCT2021-10-30
1961981255231423K211172Single Use Electrosurgical Knife with Fluid Pump SystemGEI2021-12-17
1961981734259595K211021Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatibleFGE2022-05-06
1961981086735064K210934Sphincterotome / short-wire compatible, Sterile SphincterotomeKNS2021-12-01
1961981981190425K202438Ensure Single-Use Coagulation ForcepsKGE2021-03-15
1961981254740049K202333Lockado Repositionable Hemostasis ClipPKL2021-01-14
1961981033755784K202204Tracheal Stent SystemJCT2021-09-01
1961981471959824K200071Blue Beacon Submucosal Injectable SolutionPLL2020-11-03
1961982000418660K193601Single Use Electrosurgical KnifeGEI2020-07-24
1961981973472773K190030Embrella Endoscopic Distal AttachmentFED2019-03-05
1961981444362061K182910Segmented Esophageal Stent SystemESW2019-05-29
1961981302437025K182556SureClip Repositionable Hemostasis ClipPKL2018-12-14
1961982019346629K180418Reliant(TM) Multistage Dilatation Balloon CatheterFGE2018-10-15
1961981132327418K180325Single Use MultiClip DevicePKL2018-06-01
1961981617144969K180018Disposable Hot Biopsy ForcepsKGE2018-07-05
1961981494557406K172813Esophageal Stent SystemESW2018-05-18
1961981531509513K172663Cytology BrushFDX2018-03-05
1961981151836038K172309Endoscopic Ultrasound Aspiration NeedleODG2017-09-29
1961981231174429K162466LuminScan (TM) Imaging SystemNQQ2016-11-29
1961981719956130K162226Reliant Multistage Dilatation Balloon CatheterFGE2017-01-25
1961981547202999K162064CrossBay IVF Embryo Transfer Catheter SetMQF2017-01-05
1961981307906918K161463SureClip(TM) Repositionable Hemostasis ClipPKL2017-01-06
1961981728215854K160625Disposable Hot Biopsy ForcepsKGE2016-06-14
1961981629180343K152802Grasping ForcepsOCZ2016-01-21
1961981856581071K152001Sterile Repositionable Hemostasis Clipping DevicePKL2015-12-10
1961982064640889K150434Injection NeedleFBK2015-06-02
1961981347962175K150316Polypectomy SnareFDI2015-07-30
1961981057596990
1961981064802707
1961981198436227
1961981224199379
1961981224709165
1961981235004518
1961981266557392
1961981327144467
1961981339242951
1961981356632109
1961981430439070
1961981518926786
1961981526018851
1961981579026617
1961981601838576
1961981611475086
1961981694364293
1961981958712817
1961981982818356
1961982031570367
1961982045042315
1961982047100953
1961982070297650

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PKL92025-09-08
FGE52026-04-24
FBN32026-04-03
JCT32022-07-08
KGE32021-03-15
FBK22026-05-29
FDI22026-02-21
GEI22021-12-17
ODG22021-12-06
ESW22019-05-29
SHU12026-04-24
FDS12025-06-27
LQR12024-12-16
QSW12022-10-03
KTI12022-07-20
EOQ12022-07-08
ODC12022-03-29
KNS12021-12-01
PLL12020-11-03
FED12019-03-05
FDX12018-03-05
MQF12017-01-05
NQQ12016-11-29
OCZ12016-01-21

PMN#

GUDID#

200 records. Showing 1-40. Next