FDA Registration
Active
🇳🇱 Netherlands
Applied Medical Europe
Reg #: 3009763019
·
FEI: 3009763019
·
Expires 2026
Products
24
Proprietary Names
1
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- Applied Medical Europe
- Registration Number
- 3009763019
- FEI Number
- 3009763019
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Wiekenweg 21
- City
- Amersfoort Utrecht
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K011236
Owner / Operator
- Firm Name
- APPLIED MEDICAL RESOURCES
- Operator Number
- 2027111
- Address
- 22872 AVENIDA EMPRESA, --
- City
- Rancho Santa Margarita
- State
- CA
- Postal Code
- 92688
- Country
- US
- Correspondent
- Leilani - Domingo
US Agent
- Business Name
- Applied Medical Resources
- Contact Name
- Leilani Domingo
- Address
- 22872 Avenida Empresa
- City
- Rancho Santa Margarita
- State
- CA
- ZIP
- 92688
- Country
- US
- [email protected]
- Phone
- 949 7138317
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2007-12-19 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-08-24 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2007-12-19 |
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2009-05-12 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2013-11-21 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2019-09-13 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2007-12-19 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2000-04-18 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2012-02-07 |
| Ring (Wound Protector), Drape Retention, Internal | KGW | Class 2 | General, Plastic Surgery | No | 2020-12-18 |
| Adaptor, Ureteral Catheter | EYI | Class 1 | Gastroenterology, Urology | No | 2013-11-21 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2002-12-11 |
| Clip, Vascular | DSS | Class 2 | Cardiovascular | No | 2007-12-19 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2014-01-27 |
| System, Evacuator, Fluid | FHF | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2007-11-28 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2007-12-19 |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | Class 2 | Obstetrics/Gynecology | No | 2007-12-19 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2007-12-19 |
| Stylet For Catheter, Gastro-Urology | EZB | Class 1 | Gastroenterology, Urology | No | 2007-12-19 |
Proprietary Names
GelPOINT Path Transanal Access Platform
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device