FDA Registration
Active
🇩🇪 Germany
Rommelag CDMO GmbH
Reg #: 9681630
·
FEI: 3002808845
·
Expires 2026
Products
11
Proprietary Names
22
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- Rommelag CDMO GmbH
- Registration Number
- 9681630
- FEI Number
- 3002808845
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Banhofstrasse
- City
- Sulzbach-Laufen Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- Rommelag CDMO GmbH
- Operator Number
- 10028922
- Address
- Bahnhofstrasse
- City
- Sulzbach-Laufen
- State
- Baden-Wurttemberg
- Postal Code
- 74429
- Country
- DE
- Correspondent
- Marcus Mueller
US Agent
- Business Name
- Parexel International
- Contact Name
- Sandy Beveridge
- Address
- 541 Church At North Hills St Ste 1000
- City
- Raleigh
- State
- NC
- ZIP
- 27609
- Country
- US
- [email protected]
- Phone
- 947 2958950
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2023-06-05 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2020-11-11 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2009-03-31 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2017-10-19 |
| Apparatus, Autotransfusion | CAC | Class 2 | Anesthesiology | No | 2009-03-20 |
| Accessories, Soft Lens Products | LPN | Class 2 | Ophthalmic | No | 2011-06-08 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2020-11-11 |
| Submucosal Injection Agent | PLL | Class 2 | Gastroenterology, Urology | No | 2016-12-14 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2009-03-20 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2019-01-31 |
| Lens, Contact (Other Material) - Daily | HQD | Class 2 | Ophthalmic | No | 2024-04-25 |
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
Ocean Chest Drain
Tangible Boost component A
Tangible Boost component B
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)