Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006380458

FEI Number

3006380458

Entity Name

Feel Tech Bio Co., Ltd.

City/State/Country

Dongnam-gu, Cheonan-si Chungnam, KR

Establishment Address

1079-20, Charyeonggogae-ro, GWANGDEOK-MYEON, Dongnam-gu, Cheonan-si Chungnam 31223, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Feel Tech Bio Co., Ltd. (Owner Number: 9099910)

Owner / Operator Contact Address

1079-20, Charyeonggogae-ro, Gwangdeok-myeon, Dongnam-gu, Cheonan-si, KR-44 31223, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080904

PMA Number

N/A

All Registered Proprietary Names

Feel Ject Insulin Syringe FIS-404P FIS-035 FIS-217 FIS-406B FIS-411B FIS-041 FIS-022 FIS-048 FIS-038 FIS-002 FIS-057 FIS-405P FIS-404B FIS-049 FIS-042 FIS-201 FIS-017 FIS-025 FIS-407B FIS-409P FIS-408B FIS-403P FIS-007 FIS-028 FIS-039 FIS-207 FIS-045B FIS-019 FIS-043 FIS-212 FIS-047 FIS-205 FIS-040 FIS-010 FIS-012 FIS-406P FIS-037B FIS-1001 FIS-085P FIS-074B FIS-401P FIS-059B FIS-056 FIS-085B FIS-409B FIS-403B FIS-008 FIS-037P FIS-034 FIS-055 FVS-015 FIS-215 FIS-021 FIS-032 FIS-029 FIS-023 FIS-402P FIS-026 FIS-045P FIS-071B Fine Micro Syringe FIS-161B FIS-059P FIS-071P FIS-209 FIS-0502 FIS-410P FIS-036 FIS-030 FIS-408P FIS-089P FIS-072B FIS-001 FIS-203 FIS-086P FIS-089B FIS-074P FIS-086B FIS-2502 FIS-016 FIS-024 FIS-407P FIS-405B FIS-014 FIS-210 FIS-213 FIS-087B FMS (Fine Micro Syringe) FIS-015 FIS-005 FIS-411P FVS-012 FVS-016 FIS-088B FIS-052P FIS-216 FIS-004 FIS-2001 FIS-410B FIS-202 FIS-031 FIS-214 FIS-020 FVS-014 FIS-013 FIS-044 FIS-206 FIS-006 FIS-054 FIS-003 FIS-051 FIS-073B FIS-033 FVS-013 FIS-018 FIS-401B FIS-402B FIS-046 FIS-204 FIS-058 FIS-052B FIS-050 FIS-208 FIS-009 FIS-211 FIS-053 FIS-027 FIS-011 FIS-161P FIS-072P FIS-087P FIS-088P FIS-073P FMS Feel Ject Needles Easy Touch Easy Touch Insulin Syringe Sure Fine Insulin Syringe Easy Touch PUSH-ON NEEDLE 30Gx8MM FPN-019 FPN-016 FPN-015 FPN-033 FPN-002 FPN-024 Feel Fine Insulin Pen Needle FPN-045 FPN-006 FPN-036 FPN-030 FPN-039 FPN-007 FPN-008 FPN-009 FPN-017 FPN-043 FPN-025 FPN-044 FPN-004 FPN-001 FPN-029 FPN-028 FPN-026 FPN-018 FPN-003 FPN-022 FPN-020 FPN-034 FPN-027 FPN-040 FPN-005 FPN-011 FPN-031 FPN-021 FPN-038 FPN-037 FPN-035 FPN-010 FPN-023 FPN-041 FPN-032 FPN-042

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-07-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2014-11-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-09-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-09-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-11-16
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-09-13
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-07-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2008-11-10

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

Feel Tech Bio Co., 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

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 3006380458. Last updated year: 2026. Please use registration number 3006380458 when referencing this establishment in official correspondence.