Facility

Contract Medical International GmbH

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003637635
Establishment type	Manufacture Medical Device
Location	Lauensteiner Strasse 37 DRESDEN Saxony, DE 01277
Registration status	Active · expires 2026
Parent company	CONTRACT MEDICAL INTL. GMBH (owner-operator 9049562)
Brand names	Fortress

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Introducer, Catheter
Product code DYB (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1340
Dilator, Vessel, For Percutaneous Catheterization
Product code DRE (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1310

Recalls & enforcement

Class IIOngoing2025-07-30
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

FDA inspections (1)

VAI2023-05-11
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by CONTRACT MEDICAL INTL. GMBH

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Contract Medical International GmbH (FEI 3003637635) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003637635-contract-medical-international-gmbh/

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