Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010396739

FEI Number

3010396739

Entity Name

Zhejiang UE Medical Corp.

City/State/Country

Xianju Zhejiang, CN

Establishment Address

8 Youyi Road, Baita Economic Development Zone, Xianju Zhejiang 317300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang UE Medical Corp. (Owner Number: 10044022)

Owner / Operator Contact Address

8 Youyi Road, Baita Economic Development Zone, Xianju, CN-ZJ 317300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251823

PMA Number

N/A

All Registered Proprietary Names

TAW Trolley Stand, TC201 UESCOPE VL400 Video Laryngoscope UESCOPE Single-Use Laryngoscope Blade, Size D0/D1/D2/D3/D4/D5/MD1/MD3/MD4/J3 UESCOPE TDC-2, TDC-3, TDC-4 Video Laryngoscope UE Display VL460/UE-M8-S/UE-M10S/UED-M3/UED-M3-S/VPM-T30-01/VPM-T35 Laryngoscope Blade for Single-Use, Size UED-A0/UED-A1/UED-A2/UED-A3/UED-A4/UED-MA1/UED-MC1/Ued-0/Ued-1/Ued-2/Ued-3/Ued-4 Video Laryngoscope for Tracheal Intubation (UED-A0, UED-A3,UET-A0, UET-A3) Video Laryngoscope (TDC-K4, TDC-K4-3, TD-C-III, TD-C-III-3, TD-C-IV, TD-C-IV-3, TD-C-V, TD-C-V-3) UESCOPE VL460 Video Laryngoscope Video Laryngoscopes (VL300SS-1, VL300S, VL300SM, VL300M, VL300L, VL300-MAC3, VL300-MAC2, VL300-Mill1) Video Laryngoscope for Single Use (UED-D0, UED-D1, UED-D2, UED-D3, UED-D4, UED-D5, UED-MD1, UED-MD2, UED-MD3) Video Laryngoscope (TDC-C2, TDC-C2-3, TDC-3, TDC-C3-3, TDC-C4, TDC-C4-3, TDC-K2, TDC-K2-3, TDC-K3, TDC-K3-3) Video Laryngoscopes (VL310-1-3, VL310-2-3, VL310-3-3, VL310-4-3,VL310-MAC3-3, VL310-MAC2-3, VL310-Mill1-3) Video Laryngoscopes (VL310-0, VL310-1, VL310-2, VL310-3, VL310-4,VL310-MAC3, VL310-MAC2, VL310-Mill1, VL300SS-1-3) Video Laryngoscopes (VL300S-3, VL300SM-3, VL300M-3, VL300L-3, VL300-MAC3-3, VL300-MAC2-3, VL300-Mill1-3, VL310-0-3) Video Laryngoscope for Tracheal Intubation UET-C0,UET-C1,UET-MC1,UET-C2,UET-C3,UET-C4 Video Laryngoscope for Single Use (UED-F0, UED-F1, UED-F2, UED-F3, UED-F4, UED-F5, UED-MF1, UED-MF2, UED-MF3) Video Laryngoscope for Tracheal Intubation UED-C0,UED-C1,UED-MC1,UED-C2,UED-C3,UED-C4 TAW Video Stylet, VS-10, VS-20, VS-40 UE Intubation Stylet, P1/P2/P3 UESCOPE VL400 Video Stylet Video Stylet TRS-P2, TRS-P2-3, TRS-C00, TRS-C00-3, TRS-K00, TRS-K00-3 Video Stylet TRS-C1, TRS-C1-3, TRS-K1, TRS-K1-3, TRS-C2, TRS-C2-3, TRS-K2, TRS-K2-3, TRS-D2, TRS-D2-3 Exchange Assistant UE TA Stylet SaCoVLM Disposable Laryngeal Mask, Size 1, 1.5, 2, 2.5, 3, 4, 5, 6 Disposable Medical Laryngeal Masks, MLM10, MLM15, MLM20, MLM25, MLM30, MLM40, MLM50, MLM60 Disposable Medical Laryngeal Masks, PDLM10CS, PDLM15CS, PDLM20CS, PDLM25CS, PDLM30CS, PDLM40CS, PDLM50CS Disposable Medical Laryngeal Masks, PMLM10CS, PMLM15CS, PMLM20CS, PMLM25CS, PMLM30CS, PMLM40CS, PMLM50CS Disposable Medical Laryngeal Masks, MLM10C, MLM15C, MLM20C, MLM25C, MLM30C, MLM40C, MLM50C, MLM60C Disposable Medical Laryngeal Masks, PDLM10S, PDLM15S, PDLM20S, PDLM25S, PDLM30S, PDLM40S, PDLM50S Disposable Medical Laryngeal Masks, DLM10, DLM15, DLM20, DLM25, DLM30, DLM40, DLM50, DLM60 UE BRONCHO Single-Use Bronchoscope EBS-380C, EBS-500C, EBS-600C; UE Display UE-M10S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2025-04-13
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2013-04-19
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2013-11-20
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2016-09-07
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2015-11-07
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-08-23

Official Correspondent

No official correspondent registered.

US Agent Details

Dongsheng Wei Email: dwei@uescope.com Phone: (617) 6102718

Related Public Records

Same Entity

Zhejiang UE Medical Corp.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010396739. Last updated year: 2026. Please use registration number 3010396739 when referencing this establishment in official correspondence.