Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010674

FEI Number

6064

Entity Name

ALMO-ERZEUGNISSE ERWIN BUSCH GMBH

City/State/Country

BAD AROLSEN Hesse, DE

Establishment Address

GROSSE ALLEE 84, BAD AROLSEN Hesse 34454, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ALMO ERZEUGNISSE ERWIN BUSCH GMBH (Owner Number: 9091380)

Owner / Operator Contact Address

GROSSE ALLEE 84, --, BAD AROLSEN, DE-NOTA 34454, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Injekt NORM-JECT Exadoral Omnican Omnifix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-03-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-12-02
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2007-10-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-10-09

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: B. BRAUN MEDICAL, INC. Email: kamaal.anas@bbraunusa.com Phone: (484) 5231349

Related Public Records

Same Entity

ALMO ERZEUGNISSE ERWIN BUSCH GMBH

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

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 8010674. Last updated year: 2026. Please use registration number 8010674 when referencing this establishment in official correspondence.