Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681630

FEI Number

3002808845

Entity Name

Rommelag CDMO GmbH

City/State/Country

Sulzbach-Laufen Baden-Wurttemberg, DE

Establishment Address

Banhofstrasse, Sulzbach-Laufen Baden-Wurttemberg 74429, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Rommelag CDMO GmbH (Owner Number: 10028922)

Owner / Operator Contact Address

Bahnhofstrasse, Sulzbach-Laufen, DE-BW 74429, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

0.9 % Saline Solution (USP) Film Array Respiratory Panel EZ (RPEZ) 700-2138 AMPOULE,FILLED,ELUTION,GX,EV 700-2137 AMPOULE,FILLED,WASH,GX,EV 700-4526 AMPOULE,FILLED,WASH,BCR-ABL V2, CE-IVD 700-2136 AMPOULE,FILLED,BINDING,GX,EX 700-3672 AMPOULE,FILLED,WASH, BCR-ABL Prontosan Wound Irrigation Solution 40ml Prontosan Wound Irrigation Solution 350ml Prontosan Wound Irrigation Solution 1000ml Prontosan BIOWASH Surgical Irrigation; XPERIENCE Advanced Surgical Irrigation Oasis Chest Drain Express Chest Drain PURILENS SALINE SOLUTION AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS Saljet Single Dose Sterile Saline Eleview 10mL Prontosan Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-06-05
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2020-11-11
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2009-03-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-10-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-01-28
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-04-12
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2009-03-20
LPN	Accessories, Soft Lens Products	Ophthalmic	Class 2	886.5928	2011-06-08
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2020-11-11
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2009-03-20
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2016-12-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-10-19

Official Correspondent

Marcus Mueller

US Agent Details

Sandy Beveridge Business: Parexel International Email: sandy.beveridge@parexel.com Phone: (947) 2958950

Related Public Records

Same Entity

Rommelag CDMO 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K881350	Stryker Corp.	CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM	1988-09-30
K093254	Abbott Medical Optics, Inc.	AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION	2010-09-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447
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-0028-05	Ciba Vision Corporation	2	SOLO-care Plus with Aqualube, Multi-purpose solution* AquaSoft (Private label), Multi-purpose solutionSterile**For soft lenses, CIBA Vision Corporation, Made in Canada, Assembled in Canada, Manufactured for: CIBA Vision Corporation, Duluth, GA 30097 USA. The product is distributed in units of single or twin packs containing 2 to 12 ounces of product.
Z-0129-2011	Abbott Medical Optics Inc (AMO)	2	AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans, rinses, disinfects, and stores all soft contact lenses and helps keep your eyes protected from dryness and irritation throughout the day.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681630. Last updated year: 2026. Please use registration number 9681630 when referencing this establishment in official correspondence.