TRANSCOJECT GMBH

FDA Device Registration & Listing · NEUMUENSTER Schleswig-Holstein, DE · Registration 8010803

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
8010803
FEI Number
3002655329
Entity Name
TRANSCOJECT GMBH
City/State/Country
NEUMUENSTER Schleswig-Holstein, DE
Establishment Address
RUEGENSTRASSE 8, NEUMUENSTER Schleswig-Holstein 24539, DE
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
TRANSCOJECT GMBH (Owner Number: 8010804)
Owner / Operator Contact Address
RUEGENSTRASSE 8, --, NEUMUENSTER, DE-SH 24539, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Double Syringe (ACP) System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMF Syringe, Piston General Hospital Class 2 880.5860 2015-04-13
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-07-23
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2014-02-18
FRO Dressing, Wound, Drug Unknown Class U N/A 2015-09-01

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

TRANSCOJECT 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
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30

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 8010803. Last updated year: 2026. Please use registration number 8010803 when referencing this establishment in official correspondence.
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