Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681413

FEI Number

3001570557

Entity Name

TERUMO EUROPE N.V.

City/State/Country

LEUVEN Vlaams Brabant, BE

Establishment Address

INTERLEUVENLAAN 40, LEUVEN Vlaams Brabant 3001, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Terumo Europe N.V. (Owner Number: 10034088)

Owner / Operator Contact Address

Interleuvenlaan 40, Leuven, BE-VBR 3001, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161606

PMA Number

N/A

All Registered Proprietary Names

Terumo Syringe K-Pack II Needle 27Gx3/4 Thin Wall K-Pack Embrace Active Safety Needle K-Pack II K-Pack Surshield Needle, Hypodermic Needle for Single Use SURFLO® Winged Infusion Set With Filter and Needle Protection (Surshield®) K-Pack II Needle - 21G x 2 K-Pack II Needle - 30G x 1/2" Ultra Thin Wall K-Pack II Needles 27G x 1/2 Extra Thin Wall K-Pack II Needle - 30G x 1/2" Extra Thin Wall K-Pack II Needle - 27G x 1/2" Ultra Thin Wall K-Pack II 29G SurGuard®3 Safety Hypodermic Needle K-Pack II Needle 27G & 30G Thin Wall Terumo SurGuard®3 Safety Hypodermic Needle Terumo SurGuard®3 Safety Hypodermic Needle & Terumo SurGuard®3 Hypodermic Syringe with Safety Needle K-Pack II Needle - 29Gx5/16" Thin Wall K-Pack II Needle - 29G Thin Wall Surflo Winged Infusion Set With Needle Protection (Surshield) Terumo Surguard2 Safety Needle 27G X 1/2 Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600IU/mL FSH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2010-11-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-09-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-08-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-11-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2011-06-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-03-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-04-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-10-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-11-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-08-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2011-06-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-10-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-10-16
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-10-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-07-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2010-11-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-02-10
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2010-11-04
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2011-10-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-02-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Dina Justice Business: Terumo Medical Corp Email: dina.justice@terumomedical.com Phone: (410) 3927226

Related Public Records

Same Entity

Terumo Europe N.V.

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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

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 9681413. Last updated year: 2026. Please use registration number 9681413 when referencing this establishment in official correspondence.