Facility

Advanced Medical Solutions Saal GmbH

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

Key facts

2recalls · worst Class II

—inspections in our data

—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)	3005433617
Establishment type	Manufacture Medical Device
Location	Donaustrasse 24 Saal/Donau Bavaria, DE 93342
Registration status	Active · expires 2026
Parent company	ADVANCED MEDICAL SOLUTIONS GROUP PLC (owner-operator 9031453)

Activity by year

Recalls (2)

Devices registered here (1)

Wound Dressing With Animal-Derived Material(S)
Product code KGN (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IIOngoing2024-10-01
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Class IITerminated2015-01-15
On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse

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. “Advanced Medical Solutions Saal GmbH (FEI 3005433617) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005433617-advanced-medical-solutions-saal-gmbh/

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