FDA Registration
Active
🇩🇪 Germany
OPINSTRUMENTS GMBH
Reg #: 3014268446
·
FEI: 3014268446
·
Expires 2026
Products
17
Proprietary Names
18
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- OPINSTRUMENTS GMBH
- Registration Number
- 3014268446
- FEI Number
- 3014268446
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Industriestrasse 3
- City
- Rosbach vor der Hoehe Hesse
- Country
- DE
Owner / Operator
- Firm Name
- OpInstruments GmbH
- Operator Number
- 10056684
- Address
- Industriestrasse 3
- City
- Rosbach vor der Hoehe
- State
- Hesse
- Postal Code
- 61191
- Country
- DE
- Correspondent
- Jiang Shi
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-09-01 |
| Surgical Retractor Kit | PYH | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2019-11-04 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2019-11-04 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2024-07-16 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2021-09-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-01-04 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-11-04 |
Proprietary Names
Suction Tubes
Retractors Fixtures
Retractors Fixtures, 04-1101-18
Dissector
Micro Scissors, Medical Scissors
Bile Duct Dilators
Binocular Loupes
Bone Bitting Rongeurs
Hemostatic Forceps
Micro Clamps
Micro Tissue Forceps, Tissue Forceps
Scalpels
Medical Headlight
Retractors
Needle Holders, Micro-Needle Holders
Ligature Forceps
Retractors, Spreaders, Forceps shaped retractors, BEMA Versys Retractor
Puncher
Establishment Types
Manufacture Medical Device