Swiss-American CDMO,LLC

FDA Device Registration & Listing · CARROLLTON, TX, US · Registration 1649690

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
1649690
FEI Number
3001451826
Entity Name
Swiss-American CDMO,LLC
City/State/Country
CARROLLTON, TX, US
Establishment Address
2055 Luna Rd Ste 126, CARROLLTON, TX 75006, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Swiss-American CDMO, LLC (Owner Number: 9020887)
Owner / Operator Contact Address
2055 LUNA RD., STE. 126, --, Carrollton, TX 75006, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EltaMD Dermal Wound Cleanser EpiCeram Skin Barrier Emulsion

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2009-04-06
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2025-03-03
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2025-05-05
FRO Dressing, Wound, Drug Unknown Class U N/A 2008-10-29
KMF Bandage, Liquid General Hospital Class 1 880.5090 2010-02-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2012-11-06
FRO Dressing, Wound, Drug Unknown Class U N/A 2007-10-11
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2007-10-11
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2012-11-06
FRO Dressing, Wound, Drug Unknown Class U N/A 2019-04-25
KMF Bandage, Liquid General Hospital Class 1 880.5090 2022-11-14
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2025-07-17
FRO Dressing, Wound, Drug Unknown Class U N/A 2008-10-29
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-05-26
NUC Lubricant, Personal Obstetrics/Gynecology Class 2 884.5300 2023-07-05
FON Bag, Drainage, With Adhesive, Ostomy Gastroenterology, Urology Class 1 876.5900 2012-11-06
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-05-26
FRO Dressing, Wound, Drug Unknown Class U N/A 2018-02-05
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2012-11-06

Official Correspondent

LESLI EARLSTON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Swiss-American CDMO, LLC
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
K050212 Qualis, Inc. PERSONAL WARMING JELLY 2005-03-17
K150256 Argentum Medical SILVERLON BURN CONTACT DRESSINGS 2015-04-30
K954741 Derma Sciences, Inc. DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) 1995-11-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025 3M Company Health Care Business 3m Center U
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0001-05 DeRoyal Wound Care U
Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649690. Last updated year: 2026. Please use registration number 1649690 when referencing this establishment in official correspondence.
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