TKMD RWANDA LTD

FDA Device Registration & Listing · Rwamagana, lburasirazuba Eastern Province, RW · Registration 3035455509

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035455509
FEI Number
3035455509
Entity Name
TKMD RWANDA LTD
City/State/Country
Rwamagana, lburasirazuba Eastern Province, RW
Establishment Address
Mwulire, Rwamagana, lburasirazuba Eastern Province 999051, RW
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TKMD RWANDA Ltd (Owner Number: 10092465)
Owner / Operator Contact Address
Mwulire, Rwamagana, RW-02 999051, RW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222772
PMA Number
N/A

All Registered Proprietary Names

Auto Disable Syringe Oral/Enteral Syringe with ENFit connector

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-01-10
PNR Enteral Syringes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2025-06-03

Official Correspondent

Donald Bai

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

TKMD RWANDA Ltd
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
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K203410 Shantou Wealy Medical Instrument Co.,Ltd ENFit Disposable Enteral Syringe 2021-06-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035455509. Last updated year: 2026. Please use registration number 3035455509 when referencing this establishment in official correspondence.
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